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54 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Jingzhuda (entinostat) / EOC Pharma, EddingPharm
NCT02115282: Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

Checkmark Final OS data in combination with exemestane from E2112 trial for advanced HR+ breast cancer
May 2020 - May 2020: Final OS data in combination with exemestane from E2112 trial for advanced HR+ breast cancer
Hourglass Oct 2019 - Dec 2019 : Interim OS analysis from E2113 trial for advanced HR+, HER2- breast cancer in combination with exemestane
Checkmark Interim OS analysis of E2112 trial for advanced HR+, HER2- breast cancer in combination with exemestane
Oct 2019 - Oct 2019: Interim OS analysis of E2112 trial for advanced HR+, HER2- breast cancer in combination with exemestane
More
Active, not recruiting
3
608
US, RoW
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS 275, MS-275, MS275, SNDX 275, SNDX-275, SNDX275, Exemestane, Aromasin, FCE-24304, Goserelin, ICI-118630, Goserelin Acetate, ZDX, Zoladex, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Placebo Administration, Quality-of-Life Assessment, Quality of Life Assessment
National Cancer Institute (NCI)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, HER2/Neu Negative, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
05/20
06/25
EOC103A3101, NCT03538171: Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

Active, not recruiting
3
375
RoW
Entinostat, Placebo, Exemestane
Taizhou EOC Pharma Co., Ltd.
Advanced Breast Cancer
07/21
03/23
NCT00466115: A Phase II Study of MS-275, in Combination With GM-CSF Treating Relapsed and Refractory Myeloid Malignancies

Not yet recruiting
2
18
US
MS-275, GM-CSF
Johns Hopkins University
Myelodysplastic Syndrome, Acute Myeloid Leukemia
 
04/07
NCT01349959: Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

Checkmark ASCO 2014
May 2014 - May 2014: ASCO 2014
Active, not recruiting
2
58
US
Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS 275, MS-275, MS275, SNDX 275, SNDX-275, SNDX275, Laboratory Biomarker Analysis, Pharmacological Study
National Cancer Institute (NCI)
Male Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
03/14
03/25
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
2016-002114-50: A multicenter phase II open label study to evaluate efficacy of concomitant use of pembrolizumab and entinostat in adult patients with metastatic uveal melanoma

Ongoing
2
29
Europe
Pembrolizumab, Entinostat, MK-3475, Solution for infusion, Coated tablet
Sahlgrenska University Hospital, Västra Götalandsregionen Sahlgrenska University Hospital
Patients suffering from metastatic uveal melanoma, Patients suffering from metastatic uveal melanoma, Diseases [C] - Cancer [C04]
 
 
PEMDAC, NCT02697630: Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

Completed
2
29
Europe
Pembrolizumab, Entinostat
Vastra Gotaland Region, Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
Metastatic Uveal Melanoma
01/23
01/23
NCT03552380: Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

Terminated
2
12
US
Entinostat, MS-275, SND-275, Nivolumab, Opdivo, Ipilimumab, Yervoy
Roberto Pili, Bristol-Myers Squibb, Syndax Pharmaceuticals, Indiana University School of Medicine
Renal Cell Carcinoma
06/22
02/24
NCT03765229: An Exploratory Study of Pembrolizumab Plus Entinostat in Non-Inflamed Stage III/IV Melanoma

Completed
2
11
US
Entinostat, Pembrolizumab, Keytruda
UNC Lineberger Comprehensive Cancer Center, Syndax Pharmaceuticals
Melanoma
12/22
07/23
NCT03501381: High Dose IL 2 and Entinostat in RCC

Active, not recruiting
2
46
US
Entinostat, Interleukin-2, aldesleukin
Roberto Pili, Indiana University Melvin and Bren Simon Cancer Center, Syndax Pharmaceuticals, Clinigen, Inc.
Renal Cell Carcinoma
01/23
04/24
CA209-117, 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
NCT01305499: A Trial to Evaluate Two Schedules of MS275 in Combination With 5AC in Elderly Patients With Acute Myeloid Leukemia (AML)

Active, not recruiting
2
52
US
Entinostat days 3, 10, MS275, 5AC, 5-azacitidine, Entinostat days 10,17
Hetty Carraway
Acute Myeloid Leukemia
09/21
09/24
WOOPS, NCT03978624: Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer

Active, not recruiting
2
20
US
Pembrolizumab, Keytruda, Entinostat, SNDX-275, MS-275
UNC Lineberger Comprehensive Cancer Center, Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
Bladder Cancer
01/24
11/26
NCT03179930: Combination Therapy With Entinostat and Pembrolizumab in Relapsed and Refractory Lymphomas

Active, not recruiting
2
47
US
Entinostat, Pembrolizumab
Memorial Sloan Kettering Cancer Center, Merck Sharp & Dohme LLC, Syndax Pharmaceuticals
Lymphoma, Relapsed, Refractory
06/25
06/25
ENCORE 601, NCT02437136: Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer

Checkmark Data from ENCORE 601 trial in combination with entinostat for MSS-CRC
Apr 2019 - Apr 2019: Data from ENCORE 601 trial in combination with entinostat for MSS-CRC
Checkmark P1/2 data from melanoma cohort of ENCORE-601 trial in combination with entinostat
Apr 2019 - Apr 2019: P1/2 data from melanoma cohort of ENCORE-601 trial in combination with entinostat
Checkmark Syndax Pharmaceuticals has decided not to advance the stage 1 of MSS CRC cohort of P1/2 ENCORE 601 trial
More
Completed
1b/2
196
US
entinostat, SNDX-275, MS-275, pembrolizumab, Keytruda, MK-3475, SCH 900475
Syndax Pharmaceuticals, Merck Sharp & Dohme LLC
Non-Small Cell Lung Cancer, Melanoma, Mismatch Repair-Proficient Colorectal Cancer
09/22
09/22
NCT01038778: Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer

Active, not recruiting
1/2
47
US
Aldesleukin, 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS 275, MS-275, MS275, SNDX 275, SNDX-275, SNDX275, Fludeoxyglucose F-18, 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
National Cancer Institute (NCI)
Clear Cell Renal Cell Carcinoma, Metastatic Kidney Carcinoma, Stage III Renal Cell Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7
05/19
07/25
INFORM2 NivEnt, NCT03838042 / 2018-000127-14 / ACTRN12619001768189: INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

Recruiting
1/2
91
Europe, RoW
Nivolumab and Entinostat, Opdivo
University Hospital Heidelberg, German Cancer Research Center
Solid tumour, Central nervous system (CNS) tumour
06/26
06/27
NCT04708470: A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Recruiting
1/2
107
US
Bintrafusp Alfa, NHS-IL12, Entinostat
National Cancer Institute (NCI)
Oropharyngeal Cancer, Neck Cancer, Human Papillomavirus, HPV, Anal Cancer, Cervical Cancer, Penile Cancer, Vulvar Cancer, Vaginal Cancer, Colon Cancer
12/25
12/26
MORPHEUS, NCT03280563: A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Active, not recruiting
1/2
138
US, RoW
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody, Tecentriq, Bevacizumab, Avastin, Entinostat, Exemestane, Fulvestrant, Ipatasertib, Tamoxifen, Abemaciclib
Hoffmann-La Roche
Breast Neoplasms
09/24
09/24
NCT05053971: Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors and Lymphomas

Recruiting
1/2
30
US
BET Bromodomain Inhibitor ZEN-3694, BETi ZEN-3694, ZEN 3694, ZEN-3694, ZEN003694, Core Biopsy, BIOPSY, CORE, CNB, Core Needle, Core Needle Biopsy, Needle Biopsy, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS 275, MS-275, MS275, SNDX 275, SNDX-275, SNDX275
National Cancer Institute (NCI)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Advanced Pancreatic Carcinoma, B-Cell Non-Hodgkin Lymphoma, Metastatic Pancreatic Carcinoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Pancreatic Carcinoma, Refractory T-Cell Non-Hodgkin Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
07/25
07/25
NCT05898828: Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer

Withdrawn
1/2
50
US
Nivolumab, Entinostat, Montanide(R) ISA-51 VG Adjuvant, H1299 Cell Lysates
National Cancer Institute (NCI)
Neoplasms, Esophageal Neoplasms, Esophagus Neoplasm, Esophagus Cancer, Neoplasms, Esophageal, Esophageal Cancer (EsC)
08/24
08/24
ETCTN-9844, NCT02453620: Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer

Active, not recruiting
1
57
US
Biopsy, BIOPSY_TYPE, Bx, Blood Sample, Blood, Blood Draw, Blood Specimen, Bone Scan, Bone Scintigraphy, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS 275, MS-275, MS275, SNDX 275, SNDX-275, SNDX275, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016, Ipilimumab Biosimilar CS1002, MDX 010, MDX-010, MDX-CTLA4, MDX010, Yervoy, Nivolumab, ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo, Pharmacogenomic Study, PHARMACOGENOMIC, Pharmacological Study, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
National Cancer Institute (NCI)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, Invasive Breast Carcinoma, Malignant Solid Neoplasm
04/21
09/25
NCT04631029: Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread

Completed
1
3
US
Atezolizumab, MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275, Etoposide, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP16
National Cancer Institute (NCI)
Extensive Stage Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain
12/21
07/23
NCT02936752: Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents

Active, not recruiting
1
28
US
Entinostat, HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275, Pembrolizumab, BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475
National Cancer Institute (NCI)
Myelodysplastic Syndrome
10/22
03/25
Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
INCA34176-358, NCT06263478: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease

Recruiting
3
20
Japan
INCA034176, Axatilimab
Incyte Biosciences Japan GK
Chronic Graft-versus-host-disease
09/25
03/27
NCT06585774: A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

Not yet recruiting
3
240
NA
INCA034176, Axatilimab, Placebo, Corticosteroids, prednisone, methylprednisolone, prednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
09/27
03/30
NCT04301778: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

Completed
2
5
US
Durvalumab, MEDI4736, SNDX-6352, UCB6352
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Syndax Pharmaceuticals, AstraZeneca
Unresectable Intrahepatic Cholangiocarcinoma
11/22
02/24
AGAVE-201, NCT04710576 / 2020-005107-40: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Active, not recruiting
2
241
Europe, Canada, US, RoW
Axatilimab, SNDX-6352
Syndax Pharmaceuticals
Chronic Graft-versus-host-disease
06/23
12/24
NCT06132256: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Recruiting
2
135
Europe, RoW
Axatilimab, SNDX-6352, Placebo
Syndax Pharmaceuticals, DevPro Biopharma
Idiopathic Pulmonary Fibrosis
04/25
06/25
NCT06388564: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Recruiting
2
120
Europe, Canada, US
Axatilimab, Ruxolitinib, Corticosteroids, prednisone, prednisolone, methylprednisolone
Incyte Corporation
Chronic Graft-versus-host-disease
06/27
12/29
NAHL, NCT05723055: Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Recruiting
2
9
US
Axatilimab, SNDX6532, Nivolumab, OPDIVO
University of Utah, Incyte Corporation
Hodgkin Lymphoma
04/25
04/28
NCT05491226: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Recruiting
2
35
US
Pembrolizumab, Keytruda, Radiation Therapy, Axatilimab
Stephen Shiao, Merck Sharp & Dohme LLC, Incyte Corporation
TNBC - Triple-Negative Breast Cancer, Breast Cancer
12/25
12/25
SNDX-6352-0503, NCT03604692: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD

Active, not recruiting
1/2
41
US
SNDX-6352, axatilimab
Syndax Pharmaceuticals
Chronic Graft-versus-host-disease
08/22
12/23
NCT06320405: Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid Tumors

Recruiting
1/2
38
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Paclitaxel, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Retifanlimab, INCMGA 0012, INCMGA-0012, INCMGA00012, INCMGA0012, MGA 012, MGA-012, MGA012, Retifanlimab-dlwr, Zynyz
OHSU Knight Cancer Institute, Oregon Health and Science University, Incyte Corporation
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
04/27
04/29
NCT06523556: Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Not yet recruiting
1/2
52
US
Axatilimab, Anti-M-CSFR Monoclonal Antibody SNDX-6352, SNDX 6352, SNDX-6352, SNDX6352, UCB6352, Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Survey Administration
Uma Borate, Incyte Corporation
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Myeloproliferative Neoplasm
12/25
12/26
NCT06488378: Phase Ib Study of Axatilimab in Combination with Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

Recruiting
1
20
NA
Axatilimab, SNDX-6352, Ab969.g2, C24H23FN4O3, Olaparib, Lynparza, AZD2281, KU-005943
Dana-Farber Cancer Institute, Incyte Corporation
Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
09/26
03/29
NCT05544032: Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

Available
N/A
NA
axatilimab, INCA34176
Incyte Corporation
Chronic Graft Vs. Host Disease
 
 
revumenib (SNDX-5613) / Syndax Pharma
NCT06284486: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Not yet recruiting
2
8
US
Venetoclax, ABT-199, GDC-0199, Revumenib, SNDX-5613
M.D. Anderson Cancer Center, Syndax Pharmaceuticals, Break Through Cancer, AbbVie
Acute Myeloid Leukemia
12/26
12/28
NCT06229912: A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes

Recruiting
2
15
US
Revumenib, SNDX- 5613
M.D. Anderson Cancer Center, Syndax Pharmaceuticals
Leukemia, HOX Gene
12/26
12/28
NCT05761171: A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Recruiting
2
78
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Calaspargase Pegol, Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl), Asparlas, Calaspargase Pegol-mknl, EZN-2285, SC-PEG E. Coli L-Asparaginase, Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Echocardiography, EC, Fludarabine Phosphate, 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586, Hydrocortisone Sodium Succinate, (11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt, A-Hydrocort, Buccalsone, Corlan, Cortisol Sodium Succinate, Cortop, Efcortelan, Emergent-EZ, Flebocortid, Hidroc Clora, Hycorace, Hydro-Adreson, Hydrocort, Hydrocortisone 21-Sodium Succinate, Hydrocortisone Na Succinate, Kinogen, Nordicort, Nositrol, Sinsurrene, Sodium hydrocortisone succinate, Solu-Cortef, Solu-Glyc, Lumbar Puncture, LP, Spinal Tap, Methotrexate, Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Prednisolone, (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, Adnisolone, Aprednislon, Capsoid, Cortalone, Cortisolone, Dacortin H, Decaprednil, Decortin H, Delta(1)Hydrocortisone, Delta- Cortef, Delta-Cortef, Delta-Diona, Delta-F, Delta-Phoricol, Delta1-dehydro-hydrocortisone, Deltacortril, Deltahydrocortisone, Deltasolone, Deltidrosol, Dhasolone, Di-Adreson-F, Dontisolon D, Estilsona, Fisopred, Frisolona, Gupisone, Hostacortin H, Hydeltra, Hydeltrasol, Klismacort, Kuhlprednon, Lenisolone, Lepi-Cortinolo, Linola-H N, Linola-H-Fett N, Longiprednil, Metacortandralone, Meti Derm, Meticortelone, Opredsone, Panafcortelone, Precortisyl, Pred-Clysma, Predeltilone, Predni-Coelin, Predni-Helvacort, Prednicortelone, Prednisolonum, Prelone, Prenilone, Sterane, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613, Vincristine Sulfate, Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Children's Oncology Group
Recurrent Acute Leukemia of Ambiguous Lineage, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Refractory Acute Leukemia of Ambiguous Lineage, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage, Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged, Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia, Refractory Mixed Phenotype Acute Leukemia
12/27
12/27
ACTRN12622000582752: AMLM26/T4 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - SNDX5613

Recruiting
1/2
92
 
Australasian Leukaemia & Lymphoma Group, Australasian Leukaemia & Lymphoma Group
acute myeloid leukaemia
 
 
NCT05731947: Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

Recruiting
1/2
158
US
Revumenib, SNDX-5613, Chemotherapy
Syndax Pharmaceuticals
Colorectal Cancer, Solid Tumors
12/24
08/27
Beat AML, NCT03013998: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from Beat AML trial for acute myeloid leukemia
Recruiting
1/2
2000
US
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Enasidenib, Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), GS-9973, ENTO, Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), TAK-924, MLN4924, Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21)
Beat AML, LLC
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
12/26
12/26
AUGMENT-101, NCT04065399 / 2020-004104-34: A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Calendar Jan 2024 - Dec 2024: Market entry for acute leukemias
Hourglass Feb 2024 - Mar 2024 : Q1'24 - PDUFA date from FDA for R/R KMT2Ar acute leukemia
Dec 2022 - Dec 2023: Submission in US for relapsed/refractory acute leukemia
Jul 2023 - Sep 2023: Data from AUGMENT-101 trial for r/r AML
Checkmark Updated data from P1 portion of P1/2 AUGMENT-101 trial for AML
More
Recruiting
1/2
413
Europe, Canada, US, RoW
revumenib, SNDX-5613, cobicistat
Syndax Pharmaceuticals, Syndax Pharmaceuticals, Inc
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia, Acute Leukemia of Ambiguous Lineage
12/24
12/24
SAVE, NCT05360160: A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia

Recruiting
1/2
43
US
SNDX-5613, Venetoclax, ASTX727
M.D. Anderson Cancer Center, Astex Pharmaceuticals, Inc., Syndax Pharmaceuticals
Acute Myeloid Leukemia
12/26
12/26
NCT06222580: SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Recruiting
1
30
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration and Biopsy, Gilteritinib, ASP-2215, ASP2215, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613
Uma Borate
Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
12/25
12/25
NCT05886049: Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

Recruiting
1
28
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Daunorubicin, Daunomycin, Daunorrubicina, DNR, Leukaemomycin C, Rubidomycin, Rubomycin C, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613, Transthoracic Echocardiography, TTE
National Cancer Institute (NCI)
Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation
12/27
12/27
AUGMENT-102, NCT05326516: A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from AUGMENT-102 trial for relapsed/refractory leukemias
Completed
1
30
Canada, US
Revumenib, SNDX-5613, Chemotherapy Regimen 1, Chemotherapy Regimen 2
Syndax Pharmaceuticals
Relapsed/Refractory Leukemias, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Mixed Phenotype Acute Leukemia, Acute Myeloid Leukemia, Acute Undifferentiated Leukemia
07/24
07/24
NCT06177067: Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Recruiting
1
24
US
Revumenib, SNDX-5613, Venetoclax, Venclextra®, Azacitidine, VIDAZA®, 5-azacitidine, intrathecal (IT) chemotherapy, ITMHA, methotrexate/hydrocortisone/cytarabine, Cytarabine, Ara-C, Cytosar®, Methotrexate, MTX, Trexall®
St. Jude Children's Research Hospital, Syndax Pharmaceuticals
Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Acute Leukemia of Ambiguous Lineage
01/26
07/26
NCT05406817: Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Recruiting
1
8
US
Revumenib, SNDX-5613
Syndax Pharmaceuticals
Acute Leukemia
09/24
12/24
NCT06226571: A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Recruiting
1
76
US
SNDX-5613, Chemotherapy Regimen, HiDAC
Syndax Pharmaceuticals
Acute Myeloid Leukemias
02/27
02/27
NCT06313437: Revumenib in Combination With 7+3 + Midostaurin in AML

Not yet recruiting
1
22
US
Revumenib, SNDX-5613, Trans N-ethyl-2-((4-(7-((4-(ethylsulfonamido)cyclohexyl)methyl)-2,7-diazaspiro[3.5]nonan-2- yl)pyrimidin-5-yl)oxy)-5-fluoro-N-isopropylbenzamide, Midostaurin, Rydapt, Cytarabine, cytosine arabinoside (ara-C), Daunorubicin, Daunomycin
Maximilian Stahl, MD, Syndax Pharmaceuticals
Acute Myeloid Leukemia, AML, Adult, AML With Gene Mutations, AML, Leukemia
03/26
03/27
NCT06575296: Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

Not yet recruiting
1
27
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Echocardiography, EC, Electronic Health Record Review, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration, Revumenib, Menin-Mixed Lineage Leukemia Protein-Protein Interaction Inhibitor SNDX-5613, Menin-MLL Inhibitor SNDX-5613, Menin-MLL Interaction Inhibitor SNDX-5613, SNDX 5613, SNDX-5613, SNDX5613
City of Hope Medical Center, National Cancer Institute (NCI)
Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Childhood Acute Leukemia, Childhood Acute Leukemia of Ambiguous Lineage, Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia
12/25
12/25
NCT05918913: Expanded Access Program for Revumenib

Available
N/A
US
Revumenib, SNDX-5613
Syndax Pharmaceuticals
Relapsed/Refractory Acute Leukemia
 
 

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