Pharmacosmos 
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107 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Monofer (iron isomaltoside 1000) / Pharmacosmos
2010-020452-64: Iron treatment in patients with known kidney disease

Ongoing
4
100
Europe
COSMOFER, VENOFER, MONOFER, B03AB04, , Solution for infusion in administration system, COSMOFER, VENOFER, MOnofer
Hull and East Yorkshire Hospitals NHS Trust
patients with known chonic kidney disease with functional or absolute Iron deficiency Anaemia, and are greater than 18 years will be given repleacement iron therapy accoring to current local protocols and NICE guidelines
 
 
2013-004979-13: A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal Cavity Et placebokontrolleret lodtrækningsforsøg med intravenøst jern til behandling af lav blodprocent før operation hos patienter med kræft i nyre, blære eller bagerst i bugvæggen

Ongoing
4
84
Europe
Monofer, Monofer, Monofer
Rigshospitalet, 2032, Pharmacosmos A/S
Iron deficiency anaemia and anaemia of chronic disease Jernmangelanæmi og anæmi ved kronisk sygdom
 
 
2016-004439-19: Intravenous iron for treatment of anaemia before cardiac surgery

Ongoing
4
1000
Europe
Iron(III) isomaltoside 1000 (Monofer), Solution for injection/infusion, Iron(III) isomaltoside 1000 (Monofer)
Alfred Health, National Health and Medical Research Council
Anaemia, Anaemia, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2018-001669-17: ICaRAS - A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care

Ongoing
4
40
Europe
Iron Isomaltoside 100mg in 1ml solution for infusion, Solution for infusion, Iron Isomaltoside 100mg in 1ml solution for infusion
Nottingham University Hospitals NHS Trust, NIHR - Research for Patient Benefit
Iron deficiency anaemia secondary to cancer, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-004370-26: Intravenous Iron Products and Phosphaturia in patients with Chronic Kidney Disease

Not yet recruiting
4
30
Europe
Monofer, Ferinject, Solution for injection/infusion, Solution for injection, Monofer, Ferinject
Hull University Teaching Hospitals NHS Trust, Pharmacosmos A/S
Iron deficiency anaemia associated with Chronic Kidney Disease, Anaemia because of low iron associated with chronic kidney disease, Body processes [G] - Metabolic Phenomena [G03]
 
 
2019-002661-35: FERRIC-CABG: Effect of Iron Isomaltoside in Patients Undergoing CoronaryArtery Bypass Grafting +/- Valve Surgery.

Not yet recruiting
4
240
Europe
Solution for injection/infusion, MONOFER
King's College London, King's College Hospital NHS Foundation Trust, British Heart Foundation
Coronary or heart valve disease needing cardiac surgery, Coronary or heart valve disease needing cardiac surgery, Diseases [C] - Cardiovascular Diseases [C14]
 
 
2021-005383-22: Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)

Not yet recruiting
4
36
Europe
MonoFer 100 mg/ml, Solution for infusion, MonoFer 100 mg/ml
Universitätsmedizin Göttingen, Pharmacosmos A/S
Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Diseases [C] - Cardiovascular Diseases [C14]
 
 
IVIronPPH, NCT04505514: Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

Recruiting
4
60
RoW
Iron Isomaltoside 1000, Placebo, Iberet-Folic-500
University of Malaya
Post Partum Hemorrhage, Anemia
10/22
12/22
NCT04346004: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

Recruiting
4
214
RoW
Normal saline, Iron isomaltoside
Yonsei University
Aortic Stenosis (Treated With TAVI)
03/23
03/23
NCT05258825: Preoperative Monoferric for Abdominal Surgery

Not yet recruiting
4
32
US
Monoferric
Brigham and Women's Hospital, Pharmacosmos A/S
Anemia, Surgery
03/23
04/23
PICS, NCT04608539: A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery

Completed
4
110
Europe
Ferric Derisomaltose, MonoFer, iron isomaltoside 1000, Ferrous sulfate, Ferro Duretter, normal saline, 0.9% natriumchloride
Michael Kremke, Aarhus University Hospital, University of Aarhus, Pharmacosmos A/S
Anemia Postoperative
06/23
06/23
2020-001389-12: Intravenous iron for the treatment of anaemia following cardiac surgery

Not yet recruiting
4
110
Europe
Solution for injection, Tablet, MonoFer, Ferro Duretter
Aarhus University Hospital, Aarhus University Hospital, Aarhus, Pharmacosmos A/S, Holbæk
Anaemia following cardiac surgery, Anaemia following cardiac surgery, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ITACS, NCT02632760: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

Completed
4
955
RoW
Ferric carboxymaltose, ferinject, Iron isomaltoside, Placebo, No active drug
Bayside Health, National Health and Medical Research Council, Australia, Monash University
Anaemia
04/24
11/24
NCT05804071: Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy

Recruiting
4
452
RoW
Niferex, MonoFer
Qianfoshan Hospital
Iron Deficiency Anemia of Pregnancy, Iron Storage Disease
01/24
01/25
RAPIDIRON, NCT05358509: Reducing Anemia in Pregnancy in India: the Trial

Completed
4
4368
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Children's Investment Fund Foundation, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences, Sawai Mansingh Medical College
Iron Deficiency Anemia, Infant, Low Birth Weight, Anemia of Pregnancy
12/23
01/24
IVORY, NCT06350955: IV Iron-induced Hypophosphatemia After RYGB

Recruiting
4
94
Europe
Iron isomaltoside, Iron Carboxymaltose
Lucie Favre
Hypophosphatemia, Roux-en-Y Gastric Bypass
06/26
06/26
COREVIVE-HFrEF, NCT05971732: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
146
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Reduced Ejection Fraction, Iron Deficiency, Acute Heart Failure
08/24
08/25
COREVIVE-HFpEF, NCT05991128: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
170
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies, Acute Heart Failure
08/24
08/25
ChiCTR2300074150: Efficacy and Safety of Monofer (Iron Isomaltate) in the Treatment of postoperative anemia in patients with Spinal Metastasis: a Randomized, controlled, open-label Clinical trial

Not yet recruiting
4
92
 
Iron isomaltoside on the third postoperative day (according to the recommendations of the drug manufacturer), and the maximum dose of iron isomaltoside was limited to 20mg/Kg.; Ferrous succinate tablets 200mg bid on the third day after operation, a total of 400mg per day, continuous oral administration for 28 days.
Shanghai Changzheng Hospital; Shanghai Changzheng Hospital, Cosmos Pharmaceutical Technology (Beijing) Co., Ltd.
spinal metastases patients with iron deficiency anemia after operation
 
 
NCT06830941: Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Not yet recruiting
4
124
NA
Iron isomaltoside, Intravenous iron isomaltoside, Ferrous succinate, Oral ferrous succinate
Xie Jingyuan, MD, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Chinese People's Liberation Army No 455 Hospital
Renal Anemia, Peritoneal Dialysis (PD)
02/27
12/27
IRONMETHFpEF, NCT04945707: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Recruiting
4
66
US
Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric], Monoferric, Placebo, Normal Saline
Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Pharmacosmos A/S, National Institutes of Health (NIH)
Iron-deficiency, Heart Failure With Preserved Ejection Fraction
02/25
05/25
NCT05714007: The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

Recruiting
4
120
RoW
Ferric derisomaltose, MONOFER®, Ferrous succinate
Peking Union Medical College Hospital, Pharmacosmos A/S
Perioperative Anemia, Surgery, Spinal Deformity, Adult
12/25
12/25
ChiCTR2300072661: Comparison of clinical outcome and pharmacoeconomics of high-dose intravenous iron(Iron Isomaltoside Injection) and oral iron in that treatment of iron deficiency anemia

Recruiting
4
312
 
Use of iron isomaltose on a simplified scale, intravenous infusion over 15 minutes ;Polysaccharide iron complex 0.3g was used once a day for 4 months after hemoglobin returned to normal.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Bethune Foundation
Iron Deficiency Anemia
 
 
AGE-ANEMIA, NCT04913649: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Recruiting
4
310
Europe
Ferric Derisomaltose 100 MG/ML, Monofer, Sodium chloride, Placebo
dr. P. Noordzij, Pharmacosmos A/S
Iron Deficiency Anemia
09/25
12/25
ChiCTR2400083168: Application Study of Iron Isomaltoside in Patients with Iron Deficiency Anemia Six Months After Weight Loss Surgery

Not yet recruiting
4
200
 
Iron isomaltoside injection (MonoFer), administered by intravenous drip, referring to the simplified scale method of administration in the product insert. Note: The maximum single dose of ferric isomaltoside is 20 mg/kg, and according to the simplified scale, a second infusion is required every other week if a single underdose is made up.; Iron Polysaccharide Complex (NIFEREX), 150mg/day for 8 weeks by oral
The Third People's Hospital of Chengdu; Bethune Foundation, Bethune Foundation
Iron Deficiency Anemia After Weight Loss Surgery
 
 
NCT05719376: The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes

Not yet recruiting
4
302
RoW
Monofer (experimental), control group
Yonsei University
Kidney Failure, Chronic
05/26
06/26
2016-003087-40: Interest of intraveinous iron and tranexamic acid to reduce transfusion in hip fracture patients - HIFIT Study Intérêt du fer intraveineux et de l'acide tranexamique dans la réduction transfusionnelle chez les patients souffrant d'une fracture du col du fémur - Etude HIFIT

Not yet recruiting
3
780
Europe
MONOFER, EXACYL 500mg-5mL, Solution for injection, MONOFER 1000mg-10mL, EXACYL 500mg-5mL
UHangers, UHAngers
Hip fracture Fracture du col du fémur, Hip Fracture Fracture du col du fémur, Body processes [G] - Bones and nerves physological processes [G11]
 
 
2019-004583-22: Evaluation of positive effects of iron treatment for patients with the restless legs syndrome, who either received dopaminergic therapy before or not.

Not yet recruiting
3
140
Europe
Infusion, Monofer 100mg/ml Lösung zur Injektion und Infusion
Medical University of Innsbruck, Medical University of Innsbruck
Restless leg syndorme, Restless leg syndrome, Not possible to specify
 
 
NCT05251493: Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Recruiting
3
280
Canada
Iron Isomaltoside 1000, ferric derisomaltose, Monoferric DIN 22477777, Iron sucrose, iron sucrose DIN 02502917
Saskatchewan Health Authority - Regina Area, Saskatchewan Centre for Patient-Oriented Research
Iron Deficiency Anaemia in Childbirth
12/26
02/27
FORGE, NCT05467319: Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

Not yet recruiting
3
82
NA
Ferric Derisomaltose Injection, iron isomaltoside, Monoferric, Monofer, Normal saline
Alberta Health Services, Calgary, Pharmacosmos A/S
Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
09/23
12/23
NCT05304442: IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Recruiting
3
40
US
Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric], Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Baylor College of Medicine, Pharmacosmos Therapeutics, Inc.
Anemia, Iron Deficiency, Uterine Bleeding
03/25
04/25
IIOVS-01, NCT06248749: Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer

Not yet recruiting
3
200
Canada
IV iron, iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)
University of Saskatchewan
Anaemia in Ovarian Carcinoma
12/28
12/29
NCT05179226: Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Recruiting
3
200
US
Ferric Derisomaltose, Monofer®, Monoferric®
Pharmacosmos A/S
Iron Deficiency, Anaemia in Children
04/26
04/26
2024-000321-41: A phase III, prospective, open-label, multi-center trial of ferric derisomaltose in children 0 to <18 years of age with iron deficiency anemia due to non-dialysis dependent chronic kidney disease or with iron deficiency anemia who are intolerant or unresponsive to oral iron.

Not yet recruiting
3
200
US
Monoferric, Solution for injection/infusion, Monoferric
Pharmacosmos A/S, Pharmacosmos A/S
Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
FORGE II, NCT05407987: Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Recruiting
3
82
Canada
Ferric derisomaltose, MONOFERRIC, Placebo
AHS Cancer Control Alberta
Gynecologic Cancer, Anemia, Iron-deficiency
12/26
12/26
PALaDIN, NCT06884280: Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The Study

Not yet recruiting
3
30
Europe
Monofer (iron isomaltoside 1000), Ferric derisomaltose, Ferrous Sulfate
Hull University Teaching Hospitals NHS Trust, Pharmacosmos Therapeutics, Inc.
Peritoneal Dialysis, Anaemia, Iron Deficiency, Anaemia
10/27
10/27
IVIDA2, NCT05462704: Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Recruiting
3
300
US
Ferric derisomaltose, Monoferric, Ferrous sulfate, Ferosul
Women and Infants Hospital of Rhode Island, Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
Iron Deficiency Anemia, Pregnancy
03/27
03/27
2014-004133-16: The Iron and Heart Trial

Ongoing
2
84
Europe
Monofer 100mg/ml, Solution for infusion in administration system, Monofer
Hull and east Yorkshire Hospitals Trust, Kidney Research UK
Chronic Kidney Disease stages 3b to 5 with iron deficiency, Chronic Kidney Disease
 
 
2019-002037-11: Intravenous iron supplement for patients with severe aortic stenosis who have iron deficiency

Not yet recruiting
2
100
Europe
Monofer, Infusion, Monofer
Oslo University Hospital, Pharmacosmos
Iron deficiency, aortic stenosis, Iron deficeincy, aortic valve narrowing, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
2019-003819-56: Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. Effekterne af intravenøs jern hos patienter med tyk- og endetarmskræft og jernmangel, men ikke med lav blodprocent.

Not yet recruiting
2
134
Europe
Monofer, B03AC, Infusion, Monofer
Centre for Surgical Science, Pharmacosmos
Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Diseases [C] - Cancer [C04]
 
 
IIISAS, NCT04206228 / 2019-002037-11: Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Active, not recruiting
2
149
Europe
Intravenous iron isomaltoside, Monofer®, Placebo, Intravenous sodium chloride 0.9%
Oslo University Hospital, Pharmacosmos
Severe Aortic Stenosis, Iron-deficiency
03/22
03/23
NCT05913414: Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Recruiting
2
120
RoW
Iron Isomaltoside 1000, Iron isomaltoside, Polysaccharide Iron Complex Pill, Intensity-modulated radiotherapy
Sun Yat-sen University
Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
05/24
05/26
POAM, NCT06287619: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

Recruiting
2
60
Canada
Monoferric Injectable Product, Ferric derisomaltose, 0.9% sodium chloride solution
University Health Network, Toronto, Kingston Health Sciences Centre, Sunnybrook Health Sciences Centre, Heart and Stroke Foundation of Canada
Chronic Iron Deficiency Anaemia, Cardiac Surgery
12/26
06/27
NCT05763043: Monoferric for Prenatal Iron Deficiency

Recruiting
1
80
US
Ferric derisomaltose, Monoferric
Oregon Health and Science University
Obstetric Labor Complications
10/28
10/28
ChiCTR1800017010: Efficacy of preoperative intravenous iron isomaltoside in colorectal cancer surgical patients with iron deficiency anaemia compared to standard care: a pilot randomized controlled trial

Recruiting
N/A
40
 
Iron Isomaltoside 1000 Inj. (100mg/ml and 500mg/5mls), Intravenous infusion 20mg/kg (<50kg BW) or 1000mg (>50kg BW) single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation) versus Standard care(control) - no iron supplement
Department of Anaesthesia and Intensive Care, PWH; Department of Surgery, PWH, Prince of Wales Hospital, Hospital Authority
Iron deficiency anaemia; Colorectal cancer
 
 
Real-CHOICE, NCT04318405: Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery ().

Completed
N/A
327
Europe
Iron isomaltoside 1000, Iron Derisomaltose 1000
Pierre Fabre Pharma AG
Iron-Deficiency Anemia, Iron-Deficiency
11/22
11/22
NCT05545527: Neuroimaging Ancillary Study

Completed
N/A
184
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College
Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus, Iron Deficiency Anemia Treatment, Fetal Neurodevelopmental Disorder, Child Development
02/24
04/25
Hematoboost, NCT05911438: Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia

Not yet recruiting
N/A
419
RoW
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO), Basic Treatment
West China Hospital
Total Knee Arthroplasty
12/24
06/25
RAPIDIRON-KIDS, NCT05504863: RAPIDIRON Trial Follow-up Study: Study

Active, not recruiting
N/A
538
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences
Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum Disorder
01/25
01/26
OVI-IBD, NCT05581420: Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

Recruiting
N/A
152
Europe
Ferrous fumarate, MonoFer, Ferinject, Cosmofer, Venofer
Leiden University Medical Center, University Medical Center Groningen, UMC Utrecht, Rijnstate Hospital, Erasmus Medical Center, Sint Franciscus Gasthuis, Adrz, Goes, Medical Center Haaglanden
Inflammatory Bowel Diseases
05/25
05/25
Comparative iron treatment for patients with IBD and IDA, ChiCTR2200066056: A comparative study of iron isomaltoside versus traditional iron supplements in patients with inflammatory bowel diseases and iron deficiency anemia

Not yet recruiting
N/A
200
 
iron isomaltoside; traditional iron supplements
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 
ChiCTR2200066959: Study on the effect of iron supplementation on the efficacy of anti-TNF-α monoclonal antibody in patients with IBD

Not yet recruiting
N/A
200
 
iron isomaltoside ;Without intervention
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 
ChiCTR2400090696: Effect of preoperative combination of low-dose dexamethasone with iron isomaltoside on prognosis of elderly intertrochanteric hip fractures ---- Single-center, randomized, single-blind, blank controlled clinical trial

Not yet recruiting
N/A
160
 
Traditional ERAS, 250ml normal saline +10ml (1000mg Fe) iron isomaltoside injection was administered at admission, and 2ml (10mg) dexamethasone was in; Traditional ERAS
Guabgzhou First People‘s Hospital; Guabgzhou First People‘s Hospital, Guangzhou area clinical high-tech, major and characteristic technology projects
intertrochanteric hip fracture
 
 
Cosela (trilaciclib) / Pharmacosmos
NCT05071703: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed
4
30
RoW
Trilaciclib, Trilaciclib, carboplatin, etoposide#or Topotecan
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
04/22
11/22
ChiCTR2300075388: Clinical study of trilaciclib for the prevention of severe myelosuppression after chemotherapy in patients with bone and soft tissue sarcoma

Recruiting
4
550
 
Patients with bone and soft tissue sarcoma who had IV-degree bone marrow suppression in previous chemotherapy did not receive Turacilli for preventive treatment.; Patients with bone and soft tissue sarcoma who have experienced IV-degree bone marrow inhibition in chemotherapy should receive trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) before the next chemotherapy.; Patients with bone and soft tissue sarcoma will not receive prophylactic treatment until they plan to receive a high-risk chemotherapy regimen.; Before patients with bone and soft tissue sarcoma are proposed to receive high-FN-risk chemotherapy, trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) for preventive treatment.
Affiliated Sixth People's Hospital, Shanghai Jiaotong University; Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Self-financed
Bone and soft tissue sarcoma
 
 
ChiCTR2300073043: Study on the preventive effect of Cosela on chemotherapy induced bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Recruiting
4
200
 
Systemic chemotherapy with Cosela ;Systemic chemotherapy
The First Affiliated Hospital of Air Force Military Medical University; The First Affiliated Hospital of Air Force Military Medical University, Sponsored by Simcere Pharmaceutical
gastric cancer
 
 
Multiple Cohort Exploration of Trilaciclib in First-Line Combination Chemotherapy for Advanced Solid Tumors, ChiCTR2400082382: A Multi-Cohort, Open-Label, Exploratory Clinical Study of Trilaciclib in Myeloprotection in First-Line Combination Chemotherapy Regimens for Advanced Solid Tumors

Recruiting
4
25
 
Trilaciclib combined with chemotherapy
Department of Thoracic Oncology, Cancer Center, Bethune Hospital, Shanxi; Shanxi Bethune Hospital, Bethune Pioneer Medullary Protection - Bone Marrow Protection Special Research Fund Project
Advanced solid tumors
 
 
ChiCTR2500097520: A Multi-Cohort, Open-Label, Exploratory Clinical Study on the Myeloprotective and Immunomodulatory Effects of Trilaciclib in the Context of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Post-Surgery and First-Line Chemotherapy for Advanced Disease.

Not yet recruiting
4
102
 
Trilaciclib prophylaxis before chemotherapy; Trilaciclib prophylaxis before chemotherapy
Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital, The investigational drug for this project is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
 
 
ChiCTR2400086125: Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Not yet recruiting
4
50
 
Trilaciclib,Pre-chemotherapy
Datong Second People 's Hospital (Cancer Hospital); Datong Second People 's Hospital (Cancer Hospital), Not available
Small cell lung cancer
 
 
ChiCTR2400087694: A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy

Recruiting
4
20
 
Trilaciclibe
Tangdu Hospital, Fourth Military Medical University; Tangdu Hospital, Fourth Military Medical University, "Bethune Pioneer Medullary Protection" - Bone Marrow Protection Special Scientific Research Fund Project
Small cell lung cancer
 
 
NCT05874401: Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Recruiting
4
302
Europe, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor, Placebo, Topotecan, Hycamtin
G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
07/27
07/27
TRACES, NCT04902885: Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients

Checkmark Safety and efficacy data for extensive-stage small cell lung cancer
Feb 2022 - Feb 2022: Safety and efficacy data for extensive-stage small cell lung cancer
Completed
3
95
RoW
Trilaciclib, carboplatin, etoposide，or Topotecan, Trilaciclib plus chemotherapy, placebo, carboplatin, etoposide，or Topotecan, placebo plus chemotherapy
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
12/21
12/22
PRESERVE 1, NCT04607668 / 2019-003826-25: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Jan 2023 - Jun 2023: From PRESERVE1 trial for metastatic colorectal cancer
Checkmark Approved Clinical Trial Application in China for metastatic CRC
Apr 2021 - Apr 2021: Approved Clinical Trial Application in China for metastatic CRC
Terminated
3
326
Europe, US, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, Placebo
G1 Therapeutics, Inc.
Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
02/23
03/23
PRESERVE 2, NCT04799249 / 2020-004930-39: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed
3
194
Europe, US, RoW
Trilaciclib, G1T28, COSELA, Placebo, 0.9% normal saline, 5 % Dextrose in water (D5W), Gemcitabine, Carboplatin
G1 Therapeutics, Inc.
TNBC - Triple-Negative Breast Cancer, Breast Cancer
05/24
05/24
NCT06364904: A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Not yet recruiting
3
210
RoW
Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Bladder Cancer
04/27
04/29
ChiCTR2400087886: A Multicenter, Phase III, Randomized Controlled Trial on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma

Not yet recruiting
3
192
 
Induction therapy: Gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.; Induction therapy: Treacilil + gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; d) Treacilil for injection 240mg/m2, d1, 2, 8 (4 hours before chemotherapy), intravenously A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Sun Yat-Sen Clinical Research 5010 Program
muscle invasive bladder cancer
 
 
NCT05112536: Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Checkmark Initial results from P2 trial in early-stage TNBC at SABCS 2022
Dec 2022 - Dec 2022: Initial results from P2 trial in early-stage TNBC at SABCS 2022
Completed
2
24
US
Trilaciclib, COSELA®, G1T28, Cylophosphamide, CYTOXAN®, Doxorubicin, ADRIAMYCIN®, Paclitaxel, TAXOL®, Carboplatin (Investigator discretion), PARAPLATIN®, Pembrolizumab (Investigator discretion), KEYTRUDA®
G1 Therapeutics, Inc.
Triple Negative Breast Cancer, Breast Cancer
10/22
03/23
NCT06332287: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

Recruiting
2
25
RoW
combination of Trilaciclib and Pemetrexed, G1T28, CDK 4/6 inhibitor
Jiangsu Province Nanjing Brain Hospital
NSCLC
11/24
06/25
PRESERVE3, NCT04887831 / 2021-000205-24: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Hourglass Jan 2023 - Jun 2023 : Presentation of data from PRESERVE3 trial for 1L bladder cancer
Checkmark Data from PRESERVE3 trial for 1L bladder cancer
Jan 2023 - Jan 2023: Data from PRESERVE3 trial for 1L bladder cancer
Hourglass Oct 2022 - Dec 2022 : Initial data from PRESERVE 3 trial in combination with trilaciclib for 1L metastatic urothelial carcinoma
Terminated
2
92
Europe, US, RoW
Trilaciclib, Cosela, G1T28, Gemcitabine, Cisplatin, Carboplatin, Avelumab, Bavencio
G1 Therapeutics, Inc.
Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia, Metastatic Bladder Cancer
04/23
03/24
NCT05113966: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Checkmark Presentation of data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Presentation of data from P2 trial for locally advanced or metastatic TNBC
Checkmark Data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Data from P2 trial for locally advanced or metastatic TNBC
Terminated
2
30
US
Trilaciclib, G1T28, CDK 4/6 inhibitor, Sacituzumab Govitecan-hziy, Trodelvy, IMMU-132
G1 Therapeutics, Inc.
Triple Negative Breast Cancer
11/23
06/24
Trila-CN-BC-01, NCT06955156: Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Recruiting
2
50
RoW
Trilaciclib, Cosela
QIAO LI
Triple Negative Breast Cancer
05/25
07/25
NCT06328049: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

Recruiting
2
30
RoW
Trilaciclib Injection, CDK4/6 inhibitors
Taixing People's Hospital
NSCLC
02/25
08/25
NCT06151262: A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

Recruiting
2
30
RoW
Trilaciclib+mFOLFIRINOX, G1T28, CDK 4/6 inhibitor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Pancreatic Cancer
05/25
10/26
NCT06217003: Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

Not yet recruiting
2
20
RoW
Trilaciclib
The First Affiliated Hospital of Xinxiang Medical College
Osteosarcoma
02/25
08/25
NCT06297811: Myeloprotection With Trilaciclib in Pan-cancer Population

Not yet recruiting
2
132
RoW
Trilaciclib Injection, Paclitaxel, Carboplatin
Sun Yat-sen University
Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
09/25
12/27
NCT06370416: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Not yet recruiting
2
40
RoW
Trilaciclib, Trilaciclib Injection
Henan Cancer Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
04/25
12/25
NCT06569485: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

Recruiting
2
38
RoW
Trilaciclib+R-CHOP, G1T28
Sun Yat-sen University
DLBCL
12/24
12/27
NCT06490081: Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Recruiting
2
40
RoW
Trilaciclib, Trilaciclib combined with concurrent chemoradiotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Myelosuppression
01/26
06/26
NCT06569459: Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Recruiting
2
60
RoW
Trilaciclib Injection [Cosela], G1T28, CDK 4/6 inhibitor, Placebo
The First Affiliated Hospital with Nanjing Medical University
Esophageal Cancer
11/25
07/26
NCT05578326: Study of Trilaciclib and Lurbinectidin

Recruiting
2
30
US
Trilaciclib, Lurbinectedin
UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc.
Lung Cancer, Small-cell Lung Cancer
12/25
12/27
NCT06698965: Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Recruiting
2
52
RoW
Chemotherapy （Etoposide and Carboplatin）, Etoposide+Carboplatin, Immunotherapy （Envafolimab）, Envafolimab, Trilaciclib
Shanghai Chest Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Lung Cancer, Small Cell
10/29
10/29
NCT05900921: Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Not yet recruiting
2
132
NA
Trilaciclib, Carboplatin, Paclitaxel, Tislelizumab
Sichuan University, Chengdu First people's hospital, Chengdu Second people's hospital, Chengdu Seventh People's Hospital, Mianyang Central Hospital, Shanxi Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, Heilongjiang Provincial Cancer Hospital, Enshi Central Hospital, Neijiang Hospital of Traditional Chinese Medicine
Advanced Squamous Non-Small-Cell Lung Cancer
10/24
12/25
NCT06699472: A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Recruiting
2
22
RoW
Chemotherapy, VDC/IE alternating chemotherapy, Trilaciclib Injection [Cosela]
Fudan University
Ewing Sarcoma, Myelosuppression
09/26
09/27
SMA-OS-001, NCT06714383: Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Recruiting
2
50
RoW
Trilaciclib, Cosela, Pirarubicin, Lobaplatin
Peking University People's Hospital
Osteosarcoma
07/25
11/25
NCT06714266: Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting
2
30
NA
Trilaciclib, chemotherapy, immune/targeted therapy
Shandong Cancer Hospital and Institute
Head and Neck Squamous Cell Carcinoma (HNSCC)
08/26
12/26
CCRT，LA-HNSCC, NCT06752798: Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Recruiting
2
30
RoW
Trilaciclib + Cisplatin
Hunan Cancer Hospital
Head and Neck Cancer Squamous Cell Carcinoma
09/25
12/25
PROTECT-1, NCT06929936: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

Recruiting
2
33
RoW
Trilaciclib combined with Docetaxel
The First Affiliated Hospital of Xiamen University
Non-Small Cell Lung Cancer, Myelosuppression
05/26
06/26
PROTECT-2, NCT06992739: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting
2
49
NA
Trilaciclib and Sacituzumab Tirumotecan
The First Affiliated Hospital of Xiamen University
NSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression
06/26
05/27
ChiCTR2400087929: The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial

Not yet recruiting
2
10
 
Induction chemotherapy plus trilaciclib
The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University, None
Locally advanced nasopharyngeal carcinoma
 
 
NCT05910034: Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Not yet recruiting
2
132
NA
Trilaciclib+Envafolimab+Docetaxel, Envafolimab+Docetaxel, Docetaxel
Fudan University
Advanced Non-Small Cell Lung Cancer
12/25
06/26
ToPCourT, NCT06027268: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Recruiting
2
36
US
Trilaciclib, COSELA, Pembrolizumab, KEYTRUDA, Gemcitabine, Gemzar, Carboplatin
Wake Forest University Health Sciences, Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Metastatic Triple-Negative Breast Cancer
09/26
03/27
NCT05862610: The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

Not yet recruiting
2
150
NA
Trilaciclib plus chemotherapy, Trilaciclib+AC-T, Chemotherapy, AC-T
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm
12/26
06/27
SMA-BC-002, NCT05978648: Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting
2
116
RoW
Trilaciclib, COSELA®, G1T28, Epirubicin, Cyclophosphamide, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Pertuzumab
wang shusen
Breast Neoplasms
12/26
12/27
ChiCTR2500099059: Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin

Recruiting
2
52
 
Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）+Trilaciclib; Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）
Shanghai Chest Hospital; Shanghai Chest?Hospital, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd
Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan
 
 
ChiCTR2500098340: An exploratory, controlled Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in combination with PD-1 monoclonal antibody and first-line chemotherapy in patients with advanced non-small cell lung cancer

Not yet recruiting
2
40
 
Trilaciclib +PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin; PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute
non-small cell lung cancer
 
 
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
COSELA, NCT06698692: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Recruiting
N/A
200
RoW
Trilaciclib Injection [Cosela]
The First Affiliated Hospital with Nanjing Medical University
ESCC
12/24
04/25
ChiCTR2400079623: An exploratory clinical study on the efficacy and safety of trilaciclib combined with platinum-containing chemotherapy for bone marrow protection in advanced NSCLC

Recruiting
N/A
22
 
Patients with advanced NSCLC diagnosed by pathology were screened after signing informed consent, and eligible subjects were treated with trilaciclib before receiving platinum-containing double-drug chemotherapy, with a treatment cycle of 4-6 cycles. The administration regimen of trilaciclib was 240mg/m2 within 4h before chemotherapy. Dynamic changes of complete blood counts were recorded. Hematological toxicity, including febrile neutropenia and resulting infection; Transfusion of blood products and replenishment of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic antibiotic use; The QLQ-C30 scale was scored. Tumor imaging was evaluated according to RECIST1.1.
Xinyang Central Hospital; Xinyang Central Hospital, Beijing Bethune Charitable Foundation
NSCLC
 
 
ChiCTR2500097713: Myelopreservation with trilaciclib in patients with advanced ovarian carcinoma receiving paclitaxel and carboplatin: a randomized, double-blind, placebo-controlled phase II study

Not yet recruiting
N/A
71
 
240mg/m2,Q3W; 240mg/m2,Q3W
Sun yat-sen memorial hospital, Sun yat-sen university; Sun yat-sen memorial hospital, Sun yat-sen university, State Key Laboratory of Neurology and Oncology Drug Development
Advanced ovarian cancer
 
 
lerociclib (G1T38) / Walvax, Pharmacosmos
LEONARDA-1, NCT05054751: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

Completed
3
275
RoW
GB491+ Fulvestrant, test drug + Fulvestrant, Placebo+Fulvestrant, placebo control + Fulvestrant
Genor Biopharma Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
12/22
03/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Monofer (iron isomaltoside 1000) / Pharmacosmos
2010-020452-64: Iron treatment in patients with known kidney disease

Ongoing
4
100
Europe
COSMOFER, VENOFER, MONOFER, B03AB04, , Solution for infusion in administration system, COSMOFER, VENOFER, MOnofer
Hull and East Yorkshire Hospitals NHS Trust
patients with known chonic kidney disease with functional or absolute Iron deficiency Anaemia, and are greater than 18 years will be given repleacement iron therapy accoring to current local protocols and NICE guidelines
 
 
2013-004979-13: A Placebo Study Comparing Intravenous Iron with Saline in Treatment of Low Blood Count before Surgery in Patients with Cancer of the Kidney, Bladder or Lower Abdominal Cavity Et placebokontrolleret lodtrækningsforsøg med intravenøst jern til behandling af lav blodprocent før operation hos patienter med kræft i nyre, blære eller bagerst i bugvæggen

Ongoing
4
84
Europe
Monofer, Monofer, Monofer
Rigshospitalet, 2032, Pharmacosmos A/S
Iron deficiency anaemia and anaemia of chronic disease Jernmangelanæmi og anæmi ved kronisk sygdom
 
 
2016-004439-19: Intravenous iron for treatment of anaemia before cardiac surgery

Ongoing
4
1000
Europe
Iron(III) isomaltoside 1000 (Monofer), Solution for injection/infusion, Iron(III) isomaltoside 1000 (Monofer)
Alfred Health, National Health and Medical Research Council
Anaemia, Anaemia, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2018-001669-17: ICaRAS - A Feasibility Study of Intravenous Iron Therapy for Anaemia in Palliative Cancer Care

Ongoing
4
40
Europe
Iron Isomaltoside 100mg in 1ml solution for infusion, Solution for infusion, Iron Isomaltoside 100mg in 1ml solution for infusion
Nottingham University Hospitals NHS Trust, NIHR - Research for Patient Benefit
Iron deficiency anaemia secondary to cancer, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-004370-26: Intravenous Iron Products and Phosphaturia in patients with Chronic Kidney Disease

Not yet recruiting
4
30
Europe
Monofer, Ferinject, Solution for injection/infusion, Solution for injection, Monofer, Ferinject
Hull University Teaching Hospitals NHS Trust, Pharmacosmos A/S
Iron deficiency anaemia associated with Chronic Kidney Disease, Anaemia because of low iron associated with chronic kidney disease, Body processes [G] - Metabolic Phenomena [G03]
 
 
2019-002661-35: FERRIC-CABG: Effect of Iron Isomaltoside in Patients Undergoing CoronaryArtery Bypass Grafting +/- Valve Surgery.

Not yet recruiting
4
240
Europe
Solution for injection/infusion, MONOFER
King's College London, King's College Hospital NHS Foundation Trust, British Heart Foundation
Coronary or heart valve disease needing cardiac surgery, Coronary or heart valve disease needing cardiac surgery, Diseases [C] - Cardiovascular Diseases [C14]
 
 
2021-005383-22: Cognitive Function, Depression, Anxiety, and Quality of Life in Chronic Heart Failure Patients with Iron Deficiency with and without Anaemia: Effects of Intravenous Iron (Ferric Derisomaltose)

Not yet recruiting
4
36
Europe
MonoFer 100 mg/ml, Solution for infusion, MonoFer 100 mg/ml
Universitätsmedizin Göttingen, Pharmacosmos A/S
Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Iron deficiency in patients with chronic heart failure and mild cognitive impairment, Diseases [C] - Cardiovascular Diseases [C14]
 
 
IVIronPPH, NCT04505514: Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

Recruiting
4
60
RoW
Iron Isomaltoside 1000, Placebo, Iberet-Folic-500
University of Malaya
Post Partum Hemorrhage, Anemia
10/22
12/22
NCT04346004: Effect of Preoperative Iron Isomaltoside 1000 Administration on Hemoglobin Concentration in Patients Undergoing Transcatheter Aortic Valve Implantation

Recruiting
4
214
RoW
Normal saline, Iron isomaltoside
Yonsei University
Aortic Stenosis (Treated With TAVI)
03/23
03/23
NCT05258825: Preoperative Monoferric for Abdominal Surgery

Not yet recruiting
4
32
US
Monoferric
Brigham and Women's Hospital, Pharmacosmos A/S
Anemia, Surgery
03/23
04/23
PICS, NCT04608539: A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery

Completed
4
110
Europe
Ferric Derisomaltose, MonoFer, iron isomaltoside 1000, Ferrous sulfate, Ferro Duretter, normal saline, 0.9% natriumchloride
Michael Kremke, Aarhus University Hospital, University of Aarhus, Pharmacosmos A/S
Anemia Postoperative
06/23
06/23
2020-001389-12: Intravenous iron for the treatment of anaemia following cardiac surgery

Not yet recruiting
4
110
Europe
Solution for injection, Tablet, MonoFer, Ferro Duretter
Aarhus University Hospital, Aarhus University Hospital, Aarhus, Pharmacosmos A/S, Holbæk
Anaemia following cardiac surgery, Anaemia following cardiac surgery, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ITACS, NCT02632760: Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery

Completed
4
955
RoW
Ferric carboxymaltose, ferinject, Iron isomaltoside, Placebo, No active drug
Bayside Health, National Health and Medical Research Council, Australia, Monash University
Anaemia
04/24
11/24
NCT05804071: Analysis of the Effect of Iron Supplements on Iron Deficiency Anemia in Pregnancy

Recruiting
4
452
RoW
Niferex, MonoFer
Qianfoshan Hospital
Iron Deficiency Anemia of Pregnancy, Iron Storage Disease
01/24
01/25
RAPIDIRON, NCT05358509: Reducing Anemia in Pregnancy in India: the Trial

Completed
4
4368
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Children's Investment Fund Foundation, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences, Sawai Mansingh Medical College
Iron Deficiency Anemia, Infant, Low Birth Weight, Anemia of Pregnancy
12/23
01/24
IVORY, NCT06350955: IV Iron-induced Hypophosphatemia After RYGB

Recruiting
4
94
Europe
Iron isomaltoside, Iron Carboxymaltose
Lucie Favre
Hypophosphatemia, Roux-en-Y Gastric Bypass
06/26
06/26
COREVIVE-HFrEF, NCT05971732: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
146
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Reduced Ejection Fraction, Iron Deficiency, Acute Heart Failure
08/24
08/25
COREVIVE-HFpEF, NCT05991128: The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life

Recruiting
4
170
RoW
Ferric derisomaltose, Monofer, Iron (III) isomaltoside 1000, Placebo, Normal saline
China-Japan Friendship Hospital
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies, Acute Heart Failure
08/24
08/25
ChiCTR2300074150: Efficacy and Safety of Monofer (Iron Isomaltate) in the Treatment of postoperative anemia in patients with Spinal Metastasis: a Randomized, controlled, open-label Clinical trial

Not yet recruiting
4
92
 
Iron isomaltoside on the third postoperative day (according to the recommendations of the drug manufacturer), and the maximum dose of iron isomaltoside was limited to 20mg/Kg.; Ferrous succinate tablets 200mg bid on the third day after operation, a total of 400mg per day, continuous oral administration for 28 days.
Shanghai Changzheng Hospital; Shanghai Changzheng Hospital, Cosmos Pharmaceutical Technology (Beijing) Co., Ltd.
spinal metastases patients with iron deficiency anemia after operation
 
 
NCT06830941: Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients

Not yet recruiting
4
124
NA
Iron isomaltoside, Intravenous iron isomaltoside, Ferrous succinate, Oral ferrous succinate
Xie Jingyuan, MD, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Songjiang Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Chinese People's Liberation Army No 455 Hospital
Renal Anemia, Peritoneal Dialysis (PD)
02/27
12/27
IRONMETHFpEF, NCT04945707: Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Recruiting
4
66
US
Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric], Monoferric, Placebo, Normal Saline
Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Pharmacosmos A/S, National Institutes of Health (NIH)
Iron-deficiency, Heart Failure With Preserved Ejection Fraction
02/25
05/25
NCT05714007: The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

Recruiting
4
120
RoW
Ferric derisomaltose, MONOFER®, Ferrous succinate
Peking Union Medical College Hospital, Pharmacosmos A/S
Perioperative Anemia, Surgery, Spinal Deformity, Adult
12/25
12/25
ChiCTR2300072661: Comparison of clinical outcome and pharmacoeconomics of high-dose intravenous iron(Iron Isomaltoside Injection) and oral iron in that treatment of iron deficiency anemia

Recruiting
4
312
 
Use of iron isomaltose on a simplified scale, intravenous infusion over 15 minutes ;Polysaccharide iron complex 0.3g was used once a day for 4 months after hemoglobin returned to normal.
Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Bethune Foundation
Iron Deficiency Anemia
 
 
AGE-ANEMIA, NCT04913649: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients

Recruiting
4
310
Europe
Ferric Derisomaltose 100 MG/ML, Monofer, Sodium chloride, Placebo
dr. P. Noordzij, Pharmacosmos A/S
Iron Deficiency Anemia
09/25
12/25
ChiCTR2400083168: Application Study of Iron Isomaltoside in Patients with Iron Deficiency Anemia Six Months After Weight Loss Surgery

Not yet recruiting
4
200
 
Iron isomaltoside injection (MonoFer), administered by intravenous drip, referring to the simplified scale method of administration in the product insert. Note: The maximum single dose of ferric isomaltoside is 20 mg/kg, and according to the simplified scale, a second infusion is required every other week if a single underdose is made up.; Iron Polysaccharide Complex (NIFEREX), 150mg/day for 8 weeks by oral
The Third People's Hospital of Chengdu; Bethune Foundation, Bethune Foundation
Iron Deficiency Anemia After Weight Loss Surgery
 
 
NCT05719376: The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes

Not yet recruiting
4
302
RoW
Monofer (experimental), control group
Yonsei University
Kidney Failure, Chronic
05/26
06/26
2016-003087-40: Interest of intraveinous iron and tranexamic acid to reduce transfusion in hip fracture patients - HIFIT Study Intérêt du fer intraveineux et de l'acide tranexamique dans la réduction transfusionnelle chez les patients souffrant d'une fracture du col du fémur - Etude HIFIT

Not yet recruiting
3
780
Europe
MONOFER, EXACYL 500mg-5mL, Solution for injection, MONOFER 1000mg-10mL, EXACYL 500mg-5mL
UHangers, UHAngers
Hip fracture Fracture du col du fémur, Hip Fracture Fracture du col du fémur, Body processes [G] - Bones and nerves physological processes [G11]
 
 
2019-004583-22: Evaluation of positive effects of iron treatment for patients with the restless legs syndrome, who either received dopaminergic therapy before or not.

Not yet recruiting
3
140
Europe
Infusion, Monofer 100mg/ml Lösung zur Injektion und Infusion
Medical University of Innsbruck, Medical University of Innsbruck
Restless leg syndorme, Restless leg syndrome, Not possible to specify
 
 
NCT05251493: Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy

Recruiting
3
280
Canada
Iron Isomaltoside 1000, ferric derisomaltose, Monoferric DIN 22477777, Iron sucrose, iron sucrose DIN 02502917
Saskatchewan Health Authority - Regina Area, Saskatchewan Centre for Patient-Oriented Research
Iron Deficiency Anaemia in Childbirth
12/26
02/27
FORGE, NCT05467319: Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

Not yet recruiting
3
82
NA
Ferric Derisomaltose Injection, iron isomaltoside, Monoferric, Monofer, Normal saline
Alberta Health Services, Calgary, Pharmacosmos A/S
Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
09/23
12/23
NCT05304442: IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

Recruiting
3
40
US
Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric], Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Baylor College of Medicine, Pharmacosmos Therapeutics, Inc.
Anemia, Iron Deficiency, Uterine Bleeding
03/25
04/25
IIOVS-01, NCT06248749: Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian Cancer

Not yet recruiting
3
200
Canada
IV iron, iron isomaltoside (Monofer, Monoferric) ferric gluconate (FG) iron sucrose (IS)
University of Saskatchewan
Anaemia in Ovarian Carcinoma
12/28
12/29
NCT05179226: Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Recruiting
3
200
US
Ferric Derisomaltose, Monofer®, Monoferric®
Pharmacosmos A/S
Iron Deficiency, Anaemia in Children
04/26
04/26
2024-000321-41: A phase III, prospective, open-label, multi-center trial of ferric derisomaltose in children 0 to <18 years of age with iron deficiency anemia due to non-dialysis dependent chronic kidney disease or with iron deficiency anemia who are intolerant or unresponsive to oral iron.

Not yet recruiting
3
200
US
Monoferric, Solution for injection/infusion, Monoferric
Pharmacosmos A/S, Pharmacosmos A/S
Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
FORGE II, NCT05407987: Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Recruiting
3
82
Canada
Ferric derisomaltose, MONOFERRIC, Placebo
AHS Cancer Control Alberta
Gynecologic Cancer, Anemia, Iron-deficiency
12/26
12/26
PALaDIN, NCT06884280: Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The Study

Not yet recruiting
3
30
Europe
Monofer (iron isomaltoside 1000), Ferric derisomaltose, Ferrous Sulfate
Hull University Teaching Hospitals NHS Trust, Pharmacosmos Therapeutics, Inc.
Peritoneal Dialysis, Anaemia, Iron Deficiency, Anaemia
10/27
10/27
IVIDA2, NCT05462704: Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Recruiting
3
300
US
Ferric derisomaltose, Monoferric, Ferrous sulfate, Ferosul
Women and Infants Hospital of Rhode Island, Hasbro Children's Hospital, University of Michigan, Washington University School of Medicine, University of Utah, University of Alabama at Birmingham, Oregon Health and Science University, GNP Research at Heme-on-Call
Iron Deficiency Anemia, Pregnancy
03/27
03/27
2014-004133-16: The Iron and Heart Trial

Ongoing
2
84
Europe
Monofer 100mg/ml, Solution for infusion in administration system, Monofer
Hull and east Yorkshire Hospitals Trust, Kidney Research UK
Chronic Kidney Disease stages 3b to 5 with iron deficiency, Chronic Kidney Disease
 
 
2019-002037-11: Intravenous iron supplement for patients with severe aortic stenosis who have iron deficiency

Not yet recruiting
2
100
Europe
Monofer, Infusion, Monofer
Oslo University Hospital, Pharmacosmos
Iron deficiency, aortic stenosis, Iron deficeincy, aortic valve narrowing, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
2019-003819-56: Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. Effekterne af intravenøs jern hos patienter med tyk- og endetarmskræft og jernmangel, men ikke med lav blodprocent.

Not yet recruiting
2
134
Europe
Monofer, B03AC, Infusion, Monofer
Centre for Surgical Science, Pharmacosmos
Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Iron-deficiency in colorectal cancer Jernmangel ved kolorektal cancer, Diseases [C] - Cancer [C04]
 
 
IIISAS, NCT04206228 / 2019-002037-11: Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Active, not recruiting
2
149
Europe
Intravenous iron isomaltoside, Monofer®, Placebo, Intravenous sodium chloride 0.9%
Oslo University Hospital, Pharmacosmos
Severe Aortic Stenosis, Iron-deficiency
03/22
03/23
NCT05913414: Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Recruiting
2
120
RoW
Iron Isomaltoside 1000, Iron isomaltoside, Polysaccharide Iron Complex Pill, Intensity-modulated radiotherapy
Sun Yat-sen University
Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
05/24
05/26
POAM, NCT06287619: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery

Recruiting
2
60
Canada
Monoferric Injectable Product, Ferric derisomaltose, 0.9% sodium chloride solution
University Health Network, Toronto, Kingston Health Sciences Centre, Sunnybrook Health Sciences Centre, Heart and Stroke Foundation of Canada
Chronic Iron Deficiency Anaemia, Cardiac Surgery
12/26
06/27
NCT05763043: Monoferric for Prenatal Iron Deficiency

Recruiting
1
80
US
Ferric derisomaltose, Monoferric
Oregon Health and Science University
Obstetric Labor Complications
10/28
10/28
ChiCTR1800017010: Efficacy of preoperative intravenous iron isomaltoside in colorectal cancer surgical patients with iron deficiency anaemia compared to standard care: a pilot randomized controlled trial

Recruiting
N/A
40
 
Iron Isomaltoside 1000 Inj. (100mg/ml and 500mg/5mls), Intravenous infusion 20mg/kg (<50kg BW) or 1000mg (>50kg BW) single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation) versus Standard care(control) - no iron supplement
Department of Anaesthesia and Intensive Care, PWH; Department of Surgery, PWH, Prince of Wales Hospital, Hospital Authority
Iron deficiency anaemia; Colorectal cancer
 
 
Real-CHOICE, NCT04318405: Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery ().

Completed
N/A
327
Europe
Iron isomaltoside 1000, Iron Derisomaltose 1000
Pierre Fabre Pharma AG
Iron-Deficiency Anemia, Iron-Deficiency
11/22
11/22
NCT05545527: Neuroimaging Ancillary Study

Completed
N/A
184
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College
Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus, Iron Deficiency Anemia Treatment, Fetal Neurodevelopmental Disorder, Child Development
02/24
04/25
Hematoboost, NCT05911438: Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia

Not yet recruiting
N/A
419
RoW
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO), Basic Treatment
West China Hospital
Total Knee Arthroplasty
12/24
06/25
RAPIDIRON-KIDS, NCT05504863: RAPIDIRON Trial Follow-up Study: Study

Active, not recruiting
N/A
538
RoW
Ferric carboxymaltose, Iron isomaltoside, Ferric derisomaltose, Ferric Sulfate, Ferric sulphate
Thomas Jefferson University, Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences
Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum Disorder
01/25
01/26
OVI-IBD, NCT05581420: Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.

Recruiting
N/A
152
Europe
Ferrous fumarate, MonoFer, Ferinject, Cosmofer, Venofer
Leiden University Medical Center, University Medical Center Groningen, UMC Utrecht, Rijnstate Hospital, Erasmus Medical Center, Sint Franciscus Gasthuis, Adrz, Goes, Medical Center Haaglanden
Inflammatory Bowel Diseases
05/25
05/25
Comparative iron treatment for patients with IBD and IDA, ChiCTR2200066056: A comparative study of iron isomaltoside versus traditional iron supplements in patients with inflammatory bowel diseases and iron deficiency anemia

Not yet recruiting
N/A
200
 
iron isomaltoside; traditional iron supplements
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 
ChiCTR2200066959: Study on the effect of iron supplementation on the efficacy of anti-TNF-α monoclonal antibody in patients with IBD

Not yet recruiting
N/A
200
 
iron isomaltoside ;Without intervention
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Bethune Charitable Foundation
Inflammatory bowel disease
 
 
ChiCTR2400090696: Effect of preoperative combination of low-dose dexamethasone with iron isomaltoside on prognosis of elderly intertrochanteric hip fractures ---- Single-center, randomized, single-blind, blank controlled clinical trial

Not yet recruiting
N/A
160
 
Traditional ERAS, 250ml normal saline +10ml (1000mg Fe) iron isomaltoside injection was administered at admission, and 2ml (10mg) dexamethasone was in; Traditional ERAS
Guabgzhou First People‘s Hospital; Guabgzhou First People‘s Hospital, Guangzhou area clinical high-tech, major and characteristic technology projects
intertrochanteric hip fracture
 
 
Cosela (trilaciclib) / Pharmacosmos
NCT05071703: Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study

Completed
4
30
RoW
Trilaciclib, Trilaciclib, carboplatin, etoposide#or Topotecan
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
04/22
11/22
ChiCTR2300075388: Clinical study of trilaciclib for the prevention of severe myelosuppression after chemotherapy in patients with bone and soft tissue sarcoma

Recruiting
4
550
 
Patients with bone and soft tissue sarcoma who had IV-degree bone marrow suppression in previous chemotherapy did not receive Turacilli for preventive treatment.; Patients with bone and soft tissue sarcoma who have experienced IV-degree bone marrow inhibition in chemotherapy should receive trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) before the next chemotherapy.; Patients with bone and soft tissue sarcoma will not receive prophylactic treatment until they plan to receive a high-risk chemotherapy regimen.; Before patients with bone and soft tissue sarcoma are proposed to receive high-FN-risk chemotherapy, trarasili (240 mg/m2, intravenous administration within 4 hours before chemotherapy, and the number of days of medication is determined according to the number of days of chemotherapy) for preventive treatment.
Affiliated Sixth People's Hospital, Shanghai Jiaotong University; Affiliated Sixth People's Hospital, Shanghai Jiaotong University, Self-financed
Bone and soft tissue sarcoma
 
 
ChiCTR2300073043: Study on the preventive effect of Cosela on chemotherapy induced bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Recruiting
4
200
 
Systemic chemotherapy with Cosela ;Systemic chemotherapy
The First Affiliated Hospital of Air Force Military Medical University; The First Affiliated Hospital of Air Force Military Medical University, Sponsored by Simcere Pharmaceutical
gastric cancer
 
 
Multiple Cohort Exploration of Trilaciclib in First-Line Combination Chemotherapy for Advanced Solid Tumors, ChiCTR2400082382: A Multi-Cohort, Open-Label, Exploratory Clinical Study of Trilaciclib in Myeloprotection in First-Line Combination Chemotherapy Regimens for Advanced Solid Tumors

Recruiting
4
25
 
Trilaciclib combined with chemotherapy
Department of Thoracic Oncology, Cancer Center, Bethune Hospital, Shanxi; Shanxi Bethune Hospital, Bethune Pioneer Medullary Protection - Bone Marrow Protection Special Research Fund Project
Advanced solid tumors
 
 
ChiCTR2500097520: A Multi-Cohort, Open-Label, Exploratory Clinical Study on the Myeloprotective and Immunomodulatory Effects of Trilaciclib in the Context of Adjuvant Chemotherapy for Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Post-Surgery and First-Line Chemotherapy for Advanced Disease.

Not yet recruiting
4
102
 
Trilaciclib prophylaxis before chemotherapy; Trilaciclib prophylaxis before chemotherapy
Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital, The investigational drug for this project is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
 
 
ChiCTR2400086125: Trilaciclib in the treatment of small cell lung cancer chemotherapy or chemotherapy combined with immune regimen bone marrow protection multi-cohort, multi-center, open, exploratory clinical study

Not yet recruiting
4
50
 
Trilaciclib,Pre-chemotherapy
Datong Second People 's Hospital (Cancer Hospital); Datong Second People 's Hospital (Cancer Hospital), Not available
Small cell lung cancer
 
 
ChiCTR2400087694: A Single-Arm, Observational Study to Assess the Efficacy and Safety of Trilaciclib in Extensive Stage Small Cell Lung Cancer Patients with Chemotherapy Induced Grade 3/4 Myelosuppression Following Prior Chemotherapy

Recruiting
4
20
 
Trilaciclibe
Tangdu Hospital, Fourth Military Medical University; Tangdu Hospital, Fourth Military Medical University, "Bethune Pioneer Medullary Protection" - Bone Marrow Protection Special Scientific Research Fund Project
Small cell lung cancer
 
 
NCT05874401: Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

Recruiting
4
302
Europe, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, cyclin-dependent kinase 4/6 inhibitor, Placebo, Topotecan, Hycamtin
G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
07/27
07/27
TRACES, NCT04902885: Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients

Checkmark Safety and efficacy data for extensive-stage small cell lung cancer
Feb 2022 - Feb 2022: Safety and efficacy data for extensive-stage small cell lung cancer
Completed
3
95
RoW
Trilaciclib, carboplatin, etoposide，or Topotecan, Trilaciclib plus chemotherapy, placebo, carboplatin, etoposide，or Topotecan, placebo plus chemotherapy
Jiangsu Simcere Pharmaceutical Co., Ltd., G1 Therapeutics, Inc.
Extensive-stage Small-cell Lung Cancer
12/21
12/22
PRESERVE 1, NCT04607668 / 2019-003826-25: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

Jan 2023 - Jun 2023: From PRESERVE1 trial for metastatic colorectal cancer
Checkmark Approved Clinical Trial Application in China for metastatic CRC
Apr 2021 - Apr 2021: Approved Clinical Trial Application in China for metastatic CRC
Terminated
3
326
Europe, US, RoW
Trilaciclib, G1T28, CDK 4/6 inhibitor, Placebo
G1 Therapeutics, Inc.
Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
02/23
03/23
PRESERVE 2, NCT04799249 / 2020-004930-39: Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed
3
194
Europe, US, RoW
Trilaciclib, G1T28, COSELA, Placebo, 0.9% normal saline, 5 % Dextrose in water (D5W), Gemcitabine, Carboplatin
G1 Therapeutics, Inc.
TNBC - Triple-Negative Breast Cancer, Breast Cancer
05/24
05/24
NCT06364904: A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.

Not yet recruiting
3
210
RoW
Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Bladder Cancer
04/27
04/29
ChiCTR2400087886: A Multicenter, Phase III, Randomized Controlled Trial on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma

Not yet recruiting
3
192
 
Induction therapy: Gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.; Induction therapy: Treacilil + gemcitabine and cisplatin chemotherapy combined with tirelizumab immunotherapy: a) Tirellizumab: 200mg, d1, intravenous drip. b) Gemcitabine 1000mg/ m2, d1, 8, intravenously; c) Cisplatin 70 mg/m2, d2, intravenously; d) Treacilil for injection 240mg/m2, d1, 2, 8 (4 hours before chemotherapy), intravenously A 21-day course of treatment; There were 6 courses of induction chemotherapy. Tirellizumab maintenance therapy: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Sun Yat-Sen Clinical Research 5010 Program
muscle invasive bladder cancer
 
 
NCT05112536: Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer

Checkmark Initial results from P2 trial in early-stage TNBC at SABCS 2022
Dec 2022 - Dec 2022: Initial results from P2 trial in early-stage TNBC at SABCS 2022
Completed
2
24
US
Trilaciclib, COSELA®, G1T28, Cylophosphamide, CYTOXAN®, Doxorubicin, ADRIAMYCIN®, Paclitaxel, TAXOL®, Carboplatin (Investigator discretion), PARAPLATIN®, Pembrolizumab (Investigator discretion), KEYTRUDA®
G1 Therapeutics, Inc.
Triple Negative Breast Cancer, Breast Cancer
10/22
03/23
NCT06332287: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis

Recruiting
2
25
RoW
combination of Trilaciclib and Pemetrexed, G1T28, CDK 4/6 inhibitor
Jiangsu Province Nanjing Brain Hospital
NSCLC
11/24
06/25
PRESERVE3, NCT04887831 / 2021-000205-24: Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

Hourglass Jan 2023 - Jun 2023 : Presentation of data from PRESERVE3 trial for 1L bladder cancer
Checkmark Data from PRESERVE3 trial for 1L bladder cancer
Jan 2023 - Jan 2023: Data from PRESERVE3 trial for 1L bladder cancer
Hourglass Oct 2022 - Dec 2022 : Initial data from PRESERVE 3 trial in combination with trilaciclib for 1L metastatic urothelial carcinoma
Terminated
2
92
Europe, US, RoW
Trilaciclib, Cosela, G1T28, Gemcitabine, Cisplatin, Carboplatin, Avelumab, Bavencio
G1 Therapeutics, Inc.
Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia, Metastatic Bladder Cancer
04/23
03/24
NCT05113966: Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer

Checkmark Presentation of data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Presentation of data from P2 trial for locally advanced or metastatic TNBC
Checkmark Data from P2 trial for locally advanced or metastatic TNBC
Nov 2022 - Nov 2022: Data from P2 trial for locally advanced or metastatic TNBC
Terminated
2
30
US
Trilaciclib, G1T28, CDK 4/6 inhibitor, Sacituzumab Govitecan-hziy, Trodelvy, IMMU-132
G1 Therapeutics, Inc.
Triple Negative Breast Cancer
11/23
06/24
Trila-CN-BC-01, NCT06955156: Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Recruiting
2
50
RoW
Trilaciclib, Cosela
QIAO LI
Triple Negative Breast Cancer
05/25
07/25
NCT06328049: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

Recruiting
2
30
RoW
Trilaciclib Injection, CDK4/6 inhibitors
Taixing People's Hospital
NSCLC
02/25
08/25
NCT06151262: A Study of Trilaciclib Combined With mFOLFIRINOX in the Treatment of Patients With Advanced Pancreatic Cancer

Recruiting
2
30
RoW
Trilaciclib+mFOLFIRINOX, G1T28, CDK 4/6 inhibitor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Pancreatic Cancer
05/25
10/26
NCT06217003: Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

Not yet recruiting
2
20
RoW
Trilaciclib
The First Affiliated Hospital of Xinxiang Medical College
Osteosarcoma
02/25
08/25
NCT06297811: Myeloprotection With Trilaciclib in Pan-cancer Population

Not yet recruiting
2
132
RoW
Trilaciclib Injection, Paclitaxel, Carboplatin
Sun Yat-sen University
Non-Small Cell Lung Cancer, Breast Cancer, Endometrial Cancer, Cervical Cancer, Head And Neck Squamous Cell Carcinomas
09/25
12/27
NCT06370416: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib

Not yet recruiting
2
40
RoW
Trilaciclib, Trilaciclib Injection
Henan Cancer Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer
04/25
12/25
NCT06569485: A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

Recruiting
2
38
RoW
Trilaciclib+R-CHOP, G1T28
Sun Yat-sen University
DLBCL
12/24
12/27
NCT06490081: Trilaciclib Prevents Myelosuppression With Chemoradiotherapy

Recruiting
2
40
RoW
Trilaciclib, Trilaciclib combined with concurrent chemoradiotherapy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Myelosuppression
01/26
06/26
NCT06569459: Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Recruiting
2
60
RoW
Trilaciclib Injection [Cosela], G1T28, CDK 4/6 inhibitor, Placebo
The First Affiliated Hospital with Nanjing Medical University
Esophageal Cancer
11/25
07/26
NCT05578326: Study of Trilaciclib and Lurbinectidin

Recruiting
2
30
US
Trilaciclib, Lurbinectedin
UNC Lineberger Comprehensive Cancer Center, G1 Therapeutics, Inc.
Lung Cancer, Small-cell Lung Cancer
12/25
12/27
NCT06698965: Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Trilaciclib, Envafolimab, Etoposide, and Carboplatin

Recruiting
2
52
RoW
Chemotherapy （Etoposide and Carboplatin）, Etoposide+Carboplatin, Immunotherapy （Envafolimab）, Envafolimab, Trilaciclib
Shanghai Chest Hospital, Jiangsu Simcere Pharmaceutical Co., Ltd.
Lung Cancer, Small Cell
10/29
10/29
NCT05900921: Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Not yet recruiting
2
132
NA
Trilaciclib, Carboplatin, Paclitaxel, Tislelizumab
Sichuan University, Chengdu First people's hospital, Chengdu Second people's hospital, Chengdu Seventh People's Hospital, Mianyang Central Hospital, Shanxi Provincial Cancer Hospital, Shandong Provincial Cancer Hospital, Heilongjiang Provincial Cancer Hospital, Enshi Central Hospital, Neijiang Hospital of Traditional Chinese Medicine
Advanced Squamous Non-Small-Cell Lung Cancer
10/24
12/25
NCT06699472: A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib

Recruiting
2
22
RoW
Chemotherapy, VDC/IE alternating chemotherapy, Trilaciclib Injection [Cosela]
Fudan University
Ewing Sarcoma, Myelosuppression
09/26
09/27
SMA-OS-001, NCT06714383: Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of Osteosarcoma

Recruiting
2
50
RoW
Trilaciclib, Cosela, Pirarubicin, Lobaplatin
Peking University People's Hospital
Osteosarcoma
07/25
11/25
NCT06714266: Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting
2
30
NA
Trilaciclib, chemotherapy, immune/targeted therapy
Shandong Cancer Hospital and Institute
Head and Neck Squamous Cell Carcinoma (HNSCC)
08/26
12/26
CCRT，LA-HNSCC, NCT06752798: Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Recruiting
2
30
RoW
Trilaciclib + Cisplatin
Hunan Cancer Hospital
Head and Neck Cancer Squamous Cell Carcinoma
09/25
12/25
PROTECT-1, NCT06929936: Trilaciclib in Combination With Docetaxel for Second-Line and Beyond Treatment of Locally Advanced or Metastatic NSCLC

Recruiting
2
33
RoW
Trilaciclib combined with Docetaxel
The First Affiliated Hospital of Xiamen University
Non-Small Cell Lung Cancer, Myelosuppression
05/26
06/26
PROTECT-2, NCT06992739: Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)

Not yet recruiting
2
49
NA
Trilaciclib and Sacituzumab Tirumotecan
The First Affiliated Hospital of Xiamen University
NSCLC (Advanced Non-small Cell Lung Cancer), EGFR, Myelosuppression
06/26
05/27
ChiCTR2400087929: The myeloprotective effect of the CDK4/6 inhibitor, trilaciclib, in patients with locally advanced nasopharyngeal carcinoma receiving induction chemotherapy: a phase II clinical trial

Not yet recruiting
2
10
 
Induction chemotherapy plus trilaciclib
The First Affiliated Hospital of China Medical University; The First Affiliated Hospital of China Medical University, None
Locally advanced nasopharyngeal carcinoma
 
 
NCT05910034: Envafolimab Plus Docetaxel In Combination With or Without Trilaciclib Versus Docetaxel in Advanced NSCLC

Not yet recruiting
2
132
NA
Trilaciclib+Envafolimab+Docetaxel, Envafolimab+Docetaxel, Docetaxel
Fudan University
Advanced Non-Small Cell Lung Cancer
12/25
06/26
ToPCourT, NCT06027268: Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Recruiting
2
36
US
Trilaciclib, COSELA, Pembrolizumab, KEYTRUDA, Gemcitabine, Gemzar, Carboplatin
Wake Forest University Health Sciences, Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Metastatic Triple-Negative Breast Cancer
09/26
03/27
NCT05862610: The Study of Trilaciclib Combined With Chemotherapy On The Neoadjuvant Therapy of TNBC

Not yet recruiting
2
150
NA
Trilaciclib plus chemotherapy, Trilaciclib+AC-T, Chemotherapy, AC-T
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Neoplasm
12/26
06/27
SMA-BC-002, NCT05978648: Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

Recruiting
2
116
RoW
Trilaciclib, COSELA®, G1T28, Epirubicin, Cyclophosphamide, Paclitaxel, Docetaxel, Carboplatin, Trastuzumab, Pertuzumab
wang shusen
Breast Neoplasms
12/26
12/27
ChiCTR2500099059: Randomized controlled clinical study on the efficacy and safety of first-line treatment of extensive stage small cell lung cancer with combination therapy of trilaciclib, envafolimab, etoposide, and carboplatin

Recruiting
2
52
 
Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）+Trilaciclib; Chemotherapy（Etoposide+Carboplatin）+Immunotherapy（Envafolimab）
Shanghai Chest Hospital; Shanghai Chest?Hospital, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd
Extensive-stage small cell lung cancer, classified as stage IV (any T, any N, M1a/b/c) according to the 8th edition of the AJCC, or T3-4 due to multiple pulmonary nodules or tumor/nodule volume too large to be included in a tolerable radiotherapy plan
 
 
ChiCTR2500098340: An exploratory, controlled Phase II clinical study to evaluate the efficacy and safety of Trilaciclib in combination with PD-1 monoclonal antibody and first-line chemotherapy in patients with advanced non-small cell lung cancer

Not yet recruiting
2
40
 
Trilaciclib +PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin; PD-1 monoclonal antibody + pemetrexed/paclitaxel protein-bound + carboplatin
Liaoning Cancer Hospital & Institute; Liaoning Cancer Hospital & Institute
non-small cell lung cancer
 
 
I-SPY 2, NCT01042379: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Hourglass Jan 2023 - Dec 2023 : From P2 I-SPY 2 trial for invasive breast cancer
Checkmark Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Dec 2022 - Dec 2022: Presentation of data from I-SPY trial for HR+/HER2- and TNBC breast cancer at SABCS 2022
Checkmark Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
Nov 2018 - Nov 2018: Data from trial evaluating T-DM1+pertuzumab in the adjuvant setting
More
Recruiting
2
5000
US
Standard Therapy, Paclitaxel (Taxol); Doxorubicin (Adriamycin), AMG 386 with or without Trastuzumab, AMG 386 (Trebananib); (Trastuzumab) Herceptin, AMG 479 (Ganitumab) plus Metformin, Ganitumab, MK-2206 with or without Trastuzumab, (Trastuzumab) Herceptin, AMG 386 and Trastuzumab, AMG 386 (Trebananib); Trastuzumab (Herceptin), T-DM1 and Pertuzumab, T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta), Pertuzumab and Trastuzumab, Pertuzumab (Perjeta); Trastuzumab (Herceptin), Ganetespib, ABT-888, Veliparib, Neratinib, PLX3397, Pembrolizumab - 4 cycle, Talazoparib plus Irinotecan, Patritumab and Trastuzumab, Pembrolizumab - 8 cycle, SGN-LIV1A, Durvalumab plus Olaparib, SD-101 + Pembrolizumab, Tucatinib plus trastuzumab and pertuzumab, Cemiplimab, Cemiplimab plus REGN3767, Trilaciclib with or without trastuzumab + pertuzumab, Trilaciclib (G1T28); Pertuzumab (Perjeta); Trastuzumab (Herceptin), SYD985 ([vic-]trastuzumab duocarmazine), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumab, Oral Paclitaxel + Encequidar (Oraxol); Dostarlimab (TSR-042); Trastuzumab (Herceptin), Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumab, Amcenestrant, SAR439859, Amcenestrant + Abemaciclib, Amcenestrant (SAR439859), Abemaciclib (Verzenio), Amcenestrant + Letrozole, Amcenestrant (SAR439859), Letrozole (Femara), ARX788, ARX788 + Cemiplimab, VV1 + Cemiplimab, VOYAGER V1™, VSV-IFNβ-NIS, Datopotamab deruxtecan, Dato-DXd, Datopotamab deruxtecan + Durvalumab, Zanidatamab, Lasofoxifene, Z-endoxifen, ARV-471, ARV-471 + Letrozole, ARV-471 + Abemaciclib, Endoxifen + Abemaciclib, Rilvegostomig + TDXd, Dan222 + Niraparib, Sarilumab + Cemiplimab + Paclitaxel
QuantumLeap Healthcare Collaborative
Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma, TNBC - Triple-Negative Breast Cancer, HER2-positive Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Hormone Receptor Negative Tumor, Early-stage Breast Cancer, Locally Advanced Breast Cancer
12/30
12/31
COSELA, NCT06698692: Trilaciclib for the Prevention of Chemoradiotherapy-Induced Myelosuppression in Esophageal Squamous Cell Carcinoma

Recruiting
N/A
200
RoW
Trilaciclib Injection [Cosela]
The First Affiliated Hospital with Nanjing Medical University
ESCC
12/24
04/25
ChiCTR2400079623: An exploratory clinical study on the efficacy and safety of trilaciclib combined with platinum-containing chemotherapy for bone marrow protection in advanced NSCLC

Recruiting
N/A
22
 
Patients with advanced NSCLC diagnosed by pathology were screened after signing informed consent, and eligible subjects were treated with trilaciclib before receiving platinum-containing double-drug chemotherapy, with a treatment cycle of 4-6 cycles. The administration regimen of trilaciclib was 240mg/m2 within 4h before chemotherapy. Dynamic changes of complete blood counts were recorded. Hematological toxicity, including febrile neutropenia and resulting infection; Transfusion of blood products and replenishment of hematopoietic raw materials; The use of hematopoietic growth factors; Systemic antibiotic use; The QLQ-C30 scale was scored. Tumor imaging was evaluated according to RECIST1.1.
Xinyang Central Hospital; Xinyang Central Hospital, Beijing Bethune Charitable Foundation
NSCLC
 
 
ChiCTR2500097713: Myelopreservation with trilaciclib in patients with advanced ovarian carcinoma receiving paclitaxel and carboplatin: a randomized, double-blind, placebo-controlled phase II study

Not yet recruiting
N/A
71
 
240mg/m2,Q3W; 240mg/m2,Q3W
Sun yat-sen memorial hospital, Sun yat-sen university; Sun yat-sen memorial hospital, Sun yat-sen university, State Key Laboratory of Neurology and Oncology Drug Development
Advanced ovarian cancer
 
 
lerociclib (G1T38) / Walvax, Pharmacosmos
LEONARDA-1, NCT05054751: GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer

Completed
3
275
RoW
GB491+ Fulvestrant, test drug + Fulvestrant, Placebo+Fulvestrant, placebo control + Fulvestrant
Genor Biopharma Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
12/22
03/24
 

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