Onureg (azacitidine oral) / BMS  >>  Phase 2
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24 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Onureg (azacitidine oral) / BMS
ACTRN12624000738527: AMLM22/D4: The International AML Platform Consortium (IAPC) trial – Combining Oral Azacitidine and Dendritic Cell Vaccination Vididencel in maintenance (CADENCE)

Not yet recruiting
2
140
 
Australian Leukaemia and Lymphoma Group (ALLG), Australian Leukaemia and Lymphoma Group (ALLG)
Acute myeloid leukaemia (AML)
 
 
NCT01846897: Chemotherapy With or Without Epigenetic Priming in NSCLC Patients

Recruiting
2
165
US
Arm C Active Comparator: (irinotecan,docetaxel,gemcitabine,pemetrexed), Chemotherapy will consist of the treating oncologist's choice from 4 single agent regimens, including:, - irinotecan 300mg/m2, - docetaxel 75mg/m IV once every 3 weeks, - gemcitabine 1000g/mIV once every 3 weeks, - pemetrexed 500 mg/m IV days 1 and 8 of a 3 week cycle 2 IV once every 3 weeks (for non-squamous histology only), Arm A Experimental (azacitidine,entinostat), On Arm A, patients will receive 2 cycles of azacitidine 40 mg/m2/day SC days 1-6 and 8-10 and entinostat 7mg PO days 3 and 10 of a 28 day cycle., Arm B Experimental (CC-486,entinostat), On Arm B, patients will receive 2 cycles of CC-486 300 mg PO days 1-21 and entinostat 7mg PO days 3 and 10 of a 28 day cycle.
Sidney Kimmel Comprehensive Cancer Center
Epigenetic Therapy
04/15
11/15
NCT02546986 / 2014-005614-29: Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer

Checkmark Completion of enrollment in P2 trial of CC-486 + pembrolizumab in locally advanced or metastatic non-small cell lung cancer
Aug 2016 - Aug 2016: Completion of enrollment in P2 trial of CC-486 + pembrolizumab in locally advanced or metastatic non-small cell lung cancer
Active, not recruiting
2
100
Europe, US
CC-486, Oral Azacitidine, Pembrolizumab, MK-3475, Placebo
Celgene
Carcinoma, Non-Small-Cell Lung
04/17
04/24
NCT02250326 / 2014-001105-41: Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer

Completed
2
240
Europe, Canada, US
nab-paclitaxel IV, Abraxane, ABI-007, CC-486, Oral AZA, Oral azacitidine, Duravalumab
Celgene
Carcinoma, Non-Small-Cell Lung
07/17
08/23
NCT02281084 / 2014-002675-29: Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

Completed
2
65
Europe, Canada, US, RoW
Oral Azacitidine, CC-486, Durvalumab, Imfinzi, MEDI4736
Celgene
Myelodysplastic Syndromes
06/19
09/23
NCT03542266: CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

Completed
2
21
US
CC-486 Administration, Oral Azacitidine, CHOP Administration
Weill Medical College of Cornell University, Celgene Corporation
Previously Untreated Peripheral T-cell Lymphoma
03/20
07/22
2020-001165-36: A Phase 2, Monocentric, Pilot Study to evaluate safety and efficacy of CC 486 (Oral Azacitidine) Plus Best Supportive Care as maintenance of response to sc azacitidine in IPSS higher risk elderly MDS patients Studio pilota, di fase 2, monocentrico, che si propone di valutare l’efficacia e la sicurezza dell’azacitidina orale (CC-486), somministrata insieme alla miglior terapia di supporto, come trattamento di mantenimento della risposta alla azacitidina sc in soggetti anziani con SMD e con livelli di rischio IPSS più elevati

Not yet recruiting
2
10
Europe
Azacitidina Orale, [CC-486], Film-coated tablet
Dipartimento di Medicina Sperimentale e Clinica- Università di Firenze, Celgene International II Sàrl
IPSS and IPSS-R higher Risk ( INT-2 and High risk IPSS; Intermediate, high and very high risk IPSS-R) elderly Myelodysplastic syndrome (MDS) patients Pazienti anziani con Sindrome Mielodisplastica (SMD) ad alto rischio secondo IPSS e IPSS-R (INT-2 e alto rischio secondo IPSS; intermedio, alto, molto alto secondo R-IPSS), IPSS and IPSS-R higher Risk ( INT-2 and High risk IPSS; Intermediate, high and very high risk IPSS-R) elderly Myelodysplastic syndrome (MDS) patients Pazienti anziani con Sindrome Mielodisplastica (SMD) ad alto rischio secondo IPSS e IPSS-R (INT-2 e alto rischio secondo IPSS, con livello di rischio intermedio, alto, molto alto secondo R-IPSS, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-003650-23: Study to evaluate the efficacy and safety of fedratinib in combination with CC-486 in patients suffering from myelofibrosis in acute phase. Studie zur Beurteilung der Wirksamkeit und Sicherheit von Fedratinib in Kombination mit CC-486 bei Patient*innen, die an einer Myelofibrose in beschleunigter Phase leiden.

Not yet recruiting
2
44
Europe
CC-486 tablets, Capsule, hard, Film-coated tablet, Inrebic® 100 mg Hartkapseln
Martin-Luther-Universität Halle-Wittenberg, Bristol-Myers Squibb
Myeloproliferative neoplasm in accelerated phase (MPN-AP) Myeloproliferative Neoplasie in akzelerierter Phase (MPN-AP), Myeloproliferative neoplasm in accelerated phase (MPN-AP) Myeloproliferative Neoplasie in beschleunigter Phase (MPN-AP), Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT03493646: Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

Completed
2
40
RoW
Azacitidine, Vidaza, CC-486, Oral azacitidine
Kirby Institute, Celgene
Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
09/20
09/21
NCT01928576: Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.

Completed
2
143
US
Azacitidine, 5-AZA, Vidaza, Entinostat, Nivolumab, Opdivo, CC-486 300
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Rising Tide Foundation, Stand Up To Cancer, Bristol-Myers Squibb, Celgene, Syndax Pharmaceuticals, Rhone-Poulenc Rorer
Non-Small Cell Lung Cancer, Epigenetic Therapy
04/23
04/23
FLO_CC-486-, NCT04806906: Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients

Active, not recruiting
2
11
Europe
CC-486, Oral Azacitidine
University of Florence
MDS, CMML
08/24
12/24
GS-US-546-5920, NCT04778410: Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Completed
2
54
Europe, US, RoW
Magrolimab, GS-4721, Azacitidine, Venetoclax, Mitoxantrone, Etoposide, Cytarabine, CC-486, Onureg
Gilead Sciences
Myeloid Malignancies
10/23
03/24
NCT06180863: Oral Azacitidine (CC-486) Epigenetic Priming and Maintenance for Adult Acute Myeloid Leukemia (AML) Patients

Withdrawn
2
US
oral azacitidine (CC-486), Onureg
Yale University, Bristol-Myers Squibb, National Cancer Institute (NCI)
Acute Myeloid Leukemia
11/28
04/29
NCT04174196: A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma

Active, not recruiting
2
21
US
CC-486, Lenalidomide, Radiation Therapy
Memorial Sloan Kettering Cancer Center
Plasmacytoma, Plasmacytoma of Bone, Multiple Myeloma
11/24
11/24
NCT05413018: An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

Recruiting
2
78
RoW
CC-486, Azacitidine, Onureg, Placebo
Bristol-Myers Squibb
Leukemia, Myeloid, Acute
01/25
03/26
NCT05197426: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

Recruiting
2
15
Japan, US
Oral Azacitidine, CC-486, BMS-986345, Onureg, Placebo
Bristol-Myers Squibb
Acute Myeloid Leukemia
01/25
04/26
NCT02816021: Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma

Active, not recruiting
2
24
US
Azacitidine, 5-azacytidine, 5-aza, Vidaza, 5-AZC, Ladakamycin, NSC-102816, Azacytidine, Pembrolizumab, Keytruda, MK-3475, SCH-900475
M.D. Anderson Cancer Center, Merck Sharp & Dohme LLC, Celgene
Melanoma and Other Malignant Neoplasms of Skin, Metastatic Melanoma
02/25
02/26
A051902, NCT04803201: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Recruiting
2
170
US
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Etoposide, Duvelisib, Oral azacitidine
Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI)
Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Follicular T-Cell Lymphoma, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype, Peripheral T-Cell Lymphoma, Not Otherwise Specified
06/25
01/26
OGILAR, NCT06022003: Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia

Recruiting
2
33
Europe
AzaCITIDine Oral Tablet, Onureg, CC-486, Xospata, Gilteritinib
French Innovative Leukemia Organisation, Acute Leukemia French Association
AML, Adult, Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation, FLT3-ITD
10/25
04/26
NCT02494258 / 2016-000069-22: A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders

Active, not recruiting
2
4
Europe, US
CC-486, Oral Azacitidine, BMS-986345, Onureg
Celgene
Hematologic Neoplasm, Neoplasms, Hematologic Malignancies
01/26
01/26
NCT03161223: Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

Recruiting
1/2
148
US
Durvalumab, MEDI4736, Pralatrexate, Folotyn, Romidepsin, Depsipeptide, 5-Azacitidine, Vidaza, Oral 5-Azacitidine
University of Virginia
Lymphoma, T-Cell
02/23
02/23
NCT04722601: A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma

Terminated
1/2
2
US
Venetoclax, Venclexta, Venclyxto, Obinutuzumab, Gazyva, CC-486, azacitidine
University of Chicago
Follicular Lymphoma
03/23
03/23
T-LGLL, NCT05141682: Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia

Recruiting
1/2
27
US
Oral Azacitidine, CC-486
John Reneau, Bristol-Myers Squibb
T-Cell Large Granular Lymphocyte Leukemia
12/24
12/25
NCT05782127: Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes

Recruiting
1/2
36
Europe
Onureg + Venetoclax, CC-486 + ABT-199
Groupe Francophone des Myelodysplasies, Bristol-Myers Squibb, AbbVie
Untreated Myelodysplastic Syndrome
11/25
11/28

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