Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 3 evaluate entinostat across diverse oncological indications, including advanced breast cancer, melanoma, prostate adenocarcinoma, renal cell carcinoma, and HPV-associated malignancies. Sponsored by government entities such as the National Cancer Institute, academic institutions, and industrial partners like Syndax Pharmaceuticals and Kyowa Kirin, these protocols encompass actively recruiting, completed, and terminated studies. These efforts evaluate entinostat as both a monotherapy and a combination partner—including with pembrolizumab—to elucidate its therapeutic potential and safety profile.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07261592 NOT_YET_RECRUITING
Bladder Cancer; Histone Deacetylase Inhibitor; Entinostat; Chemotherapy
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2025-12-01 PHASE1; PHASE2
NCT07235618 NOT_YET_RECRUITING
Locally Advanced or Metastatic Breast Cancer
Sun Yat-sen University
 2026-01-05 PHASE2
NCT07330544 RECRUITING
Breast Cancer
Zhejiang Cancer Hospital
 2025-11-24 PHASE2
NCT05053971 RECRUITING
Advanced Malignant Solid Neoplasm; Locally Advanced Pancreatic Carcinoma; Metastatic Pancreatic Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Pancreatic Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma
National Cancer Institute (NCI)
 2022-11-16 PHASE1; PHASE2
NCT03179930 ACTIVE_NOT_RECRUITING
Lymphoma; Relapsed; Refractory
Memorial Sloan Kettering Cancer Center
 2017-06-07 PHASE2
NCT07708194 RECRUITING
Breast Cancer; HER2-positive Breast Cancer; Hormone Receptor-Positive Breast Cancer; Metastatic Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
 2025-06-23 PHASE1; PHASE2
NCT07492394 RECRUITING
Breast Cancer
Hebei Medical University Fourth Hospital
 2025-09-12 PHASE2
NCT04708470 ACTIVE_NOT_RECRUITING
Oropharyngeal Cancer; Neck Cancer; Human Papillomavirus; HPV; Anal Cancer; Cervical Cancer; Penile Cancer; Vulvar Cancer; Vaginal Cancer; Colon Cancer
National Cancer Institute (NCI)
 2021-10-05 PHASE1; PHASE2
NCT03838042 RECRUITING
CNS Tumor; Solid Tumor
University Hospital Heidelberg
 2020-05-26 PHASE1; PHASE2
NCT07441486 NOT_YET_RECRUITING
Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
 2026-04-01 PHASE2
NCT03280563 COMPLETED
Breast Neoplasms
Hoffmann-La Roche
 2017-12-22 PHASE1; PHASE2
NCT05898828 WITHDRAWN
Neoplasms; Esophageal Neoplasms; Esophagus Neoplasm; Esophagus Cancer; Neoplasms, Esophageal; Esophageal Cancer (EsC)
National Cancer Institute (NCI)
 2024-08-02 PHASE1; PHASE2
NCT03024437 TERMINATED
Metastatic Cancer; Renal Cancer
Roberto Pili
 2017-06-29 PHASE1; PHASE2
NCT03978624 ACTIVE_NOT_RECRUITING
Bladder Cancer
UNC Lineberger Comprehensive Cancer Center
 2020-09-23 PHASE2
NCT01928576 COMPLETED
Non-Small Cell Lung Cancer; Epigenetic Therapy
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2013-11-06 PHASE2
NCT02697630 COMPLETED
Metastatic Uveal Melanoma
Vastra Gotaland Region
 2018-02-21 PHASE2
NCT03501381 ACTIVE_NOT_RECRUITING
Renal Cell Carcinoma
Roberto Pili
 2018-05-24 PHASE2
NCT03765229 COMPLETED
Melanoma
UNC Lineberger Comprehensive Cancer Center
 2019-03-22 PHASE2
NCT02936752 COMPLETED
Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2017-06-23 PHASE1
NCT02437136 COMPLETED
Non-Small Cell Lung Cancer; Melanoma; Mismatch Repair-Proficient Colorectal Cancer
Syndax Pharmaceuticals
 2015-08-26 PHASE1; PHASE2
NCT03760614 WITHDRAWN
Pancreas Cancer
Abramson Cancer Center at Penn Medicine
 2021-01 PHASE1
NCT03552380 TERMINATED
Renal Cell Carcinoma
Roberto Pili
 2018-07-31 PHASE2
NCT03924245 TERMINATED
Fallopian Tube Cancer; Fallopian Tube Carcinosarcoma; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; High Grade Fallopian Tube Serous Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Ovarian Carcinosarcoma; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Endometrial Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
Vanderbilt-Ingram Cancer Center
 2020-10-01 PHASE1
NCT04631029 COMPLETED
Extensive Stage Lung Small Cell Carcinoma; Malignant Solid Neoplasm; Metastatic Malignant Neoplasm in the Brain
National Cancer Institute (NCI)
 2021-04-27 PHASE1
NCT04296942 TERMINATED
Breast Cancer; Triple Negative Breast Cancer; HER2+ Breast Cancer; Hormone Receptor Negative Breast Cancer; Metastatic Breast Cancer
National Cancer Institute (NCI)
 2021-05-04 PHASE1
NCT04708470 Recruiting
Oropharyngeal Cancer|Neck Cancer|Human Papillomavirus|HPV|Anal Cancer|Cervical Cancer|Penile Cancer|Vulvar Cancer|Vaginal Cancer|Colon Cancer
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2021-10-05 Phase 1|Phase 2
NCT01305499 UNKNOWN
Acute Myeloid Leukemia
Hetty Carraway
 2011-07-01 PHASE2
NCT03473639 COMPLETED
Metastatic Breast Cancer; Breast Cancer
University of Virginia
 2019-01-29 PHASE1
NCT03211988 TERMINATED
Neuroendocrine Tumors
Antonio Fojo
 2017-12-13 PHASE2
NCT03538171 UNKNOWN
Advanced Breast Cancer
Taizhou EOC Pharma Co., Ltd.
 2018-05-15 PHASE3
NCT02780804 COMPLETED
Brain Stem Neoplasm; Pineal Region Neoplasm; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Primary Central Nervous System Neoplasm; Recurrent Visual Pathway Glioma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Primary Central Nervous System Neoplasm; Refractory Visual Pathway Glioma
National Cancer Institute (NCI)
 2017-01-06 PHASE1
NCT02453620 ACTIVE_NOT_RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Breast Adenocarcinoma; Invasive Breast Carcinoma; Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2016-02-12 PHASE1
NCT02708680 COMPLETED
Breast Cancer
Syndax Pharmaceuticals
 2016-05 PHASE1; PHASE2
NCT03250273 COMPLETED
Metastatic Cholangiocarcinoma; Cholangiocarcinoma; Pancreatic Cancer; Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer; Unresectable Cholangiocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2017-11-06 PHASE2
NCT03925428 WITHDRAWN
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage III T-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma; Ann Arbor Stage IV T-Cell Non-Hodgkin Lymphoma; 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 IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Carcinoma
National Cancer Institute (NCI)
 2020-09-18 PHASE1
NCT03829930 TERMINATED
Prostate Adenocarcinoma
George Washington University
 2019-05-01 PHASE1
NCT03215264 COMPLETED
Colorectal Cancer
Abramson Cancer Center at Penn Medicine
 2017-10-02 PHASE1
NCT02115282 ACTIVE_NOT_RECRUITING
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
National Cancer Institute (NCI)
 2014-03-29 PHASE3
NCT03361800 TERMINATED
Breast Cancer; Invasive Breast Cancer; ER-Negative PR-Negative HER2-Negative Breast Cancer
UNC Lineberger Comprehensive Cancer Center
 2018-11-28 EARLY_PHASE1
NCT02909452 COMPLETED
Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Breast Diseases; Renal Neoplasm; Solid Tumors
Syndax Pharmaceuticals
 2016-09-20 PHASE1
NCT01038778 ACTIVE_NOT_RECRUITING
Clear Cell Renal Cell Carcinoma; Metastatic Kidney Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
 2009-10-29 PHASE1; PHASE2
NCT03829930 Terminated
Prostate Adenocarcinoma
George Washington University
 2019-05-01 Phase 1
NCT03291886 COMPLETED
Advanced or Recurrent Breast Cancer
Kyowa Kirin Co., Ltd.
 2017-09-22 PHASE2
NCT03765229 Completed
Melanoma
UNC Lineberger Comprehensive Cancer Center|Syndax Pharmaceuticals
 2019-03-22 Phase 2
NCT02915523 COMPLETED
Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
Syndax Pharmaceuticals
 2016-12-19 PHASE1; PHASE2
NCT03473639 Completed
Metastatic Breast Cancer|Breast Cancer
University of Virginia|Syndax Pharmaceuticals
 2019-01-29 Phase 1
NCT02820961 COMPLETED
Breast Cancer; Estrogen Receptor Positive Breast Cancer
Syndax Pharmaceuticals
 2016-06-29 PHASE1
NCT02833155 COMPLETED
Breast Cancer
Taizhou EOC Pharma Co., Ltd.
 2016-08-29 PHASE1
NCT03018249 COMPLETED
FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 3 Endometrial Endometrioid Adenocarcinoma
National Cancer Institute (NCI)
 2017-10-11 EARLY_PHASE1
NCT03192111 COMPLETED
Renal Impairment; Healthy Volunteer
Syndax Pharmaceuticals
 2017-07-27 PHASE1
NCT03187015 COMPLETED
Drug Interaction; Healthy Volunteer
Syndax Pharmaceuticals
 2017-05-23 PHASE1
NCT02922946 COMPLETED
Volunteers; Healthy Volunteers; Human Volunteers; Normal Volunteers
Syndax Pharmaceuticals
 2016-10-11 PHASE1
NCT01234532 TERMINATED
Estrogen Receptor-negative Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-negative Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Triple-negative Breast Cancer
University of Maryland, Baltimore
 2010-10 PHASE2
NCT02922933 COMPLETED
Volunteers; Healthy Volunteers; Human Volunteers; Normal Volunteers
Syndax Pharmaceuticals
 2016-10-25 PHASE1
NCT01935947 TERMINATED
Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
National Cancer Institute (NCI)
 2013-05 PHASE2
NCT02897778 COMPLETED
Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Breast Neoplasms; Breast Diseases; Renal Neoplasm; Solid Tumors
Syndax Pharmaceuticals
 2016-08-24 PHASE1
NCT01434303 COMPLETED
HER2/Neu Positive; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
 2012-01-10 PHASE1
NCT02115594 WITHDRAWN
Breast Cancer
Syndax Pharmaceuticals
 2014-04 PHASE2
NCT01886573 TERMINATED
Stage IA Non-Small Cell Lung Carcinoma; Stage IB Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer
National Cancer Institute (NCI)
 2013-06 PHASE1
NCT01132573 COMPLETED
Acute Leukemias of Ambiguous Lineage; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2010-04 PHASE1
NCT00387465 COMPLETED
Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
National Cancer Institute (NCI)
 2006-08 PHASE1; PHASE2
NCT01594398 COMPLETED
Lung Cancer; Non Small Cell Lung Cancer (NSCLC); Breast Cancer; Estrogen Receptor Breast Cancer
Syndax Pharmaceuticals
 2012-05 PHASE1
NCT01349959 COMPLETED
Male Breast Carcinoma; Recurrent Breast Carcinoma; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Triple-Negative Breast Carcinoma
National Cancer Institute (NCI)
 2011-08-15 PHASE2
NCT01159301 TERMINATED
Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Blastic Phase Chronic Myelogenous Leukemia; Recurrent Adult Acute Myeloid Leukemia; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2010-06 PHASE1
NCT00313586 COMPLETED
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA; Alkylating Agent-Related Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndrome; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2006-08 PHASE2
NCT01207726 TERMINATED
Stage IA Non-Small Cell Lung Carcinoma; Stage IB Non-Small Cell Lung Carcinoma
National Cancer Institute (NCI)
 2010-09 PHASE2
NCT00866333 TERMINATED
Hodgkin's Lymphoma
Syndax Pharmaceuticals
 2009-04-13 PHASE2
NCT01383447 TERMINATED
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
 2010-10 PHASE1; PHASE2
NCT01105377 COMPLETED
Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer
National Cancer Institute (NCI)
 2010-04 PHASE2
NCT00101179 COMPLETED
Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndrome; Leukemia; Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2004-11-03 PHASE1
NCT00462605 COMPLETED
Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Ringed Sideroblasts; Refractory Cytopenia With Multilineage Dysplasia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2007-04 PHASE2
NCT00676663 COMPLETED
Breast Cancer; Estrogen Receptor-Positive Breast Cancer; Breast Cancer, Estrogen Receptor-Positive; ER+ Breast Cancer
Syndax Pharmaceuticals
 2008-06-13 PHASE2
NCT00750698 TERMINATED
Non Small Cell Lung Cancer
Syndax Pharmaceuticals
 2008-08 PHASE2
NCT00602030 COMPLETED
Non-Small-Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung
Syndax Pharmaceuticals
 2008-01-08 PHASE1; PHASE2
NCT00828854 COMPLETED
ER+ Breast Cancer
Syndax Pharmaceuticals
 2008-10-01 PHASE2
NCT00020579 COMPLETED
Cancer
National Institutes of Health Clinical Center (CC)
 2001-03 PHASE1
NCT00098891 COMPLETED
Adult Grade III Lymphomatoid Granulomatosis; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia
National Cancer Institute (NCI)
 2004-10 PHASE1
NCT00185302 COMPLETED
Melanoma
Bayer
 2004-12 PHASE2
NCT00015925 COMPLETED
Leukemia; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2001-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-03)

Check the Entinostat (MS-275) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Entinostat is a potent benzamide derivative that selectively binds to and inhibits histone deacetylases HDAC1 and HDAC3, thereby blocking histone deacetylation and altering gene transcription pathways. This biochemical blockade induces cell cycle arrest, autophagy, and apoptosis in target cells, suppressing tumor proliferation in clinical contexts such as metastatic breast cancer, prostate adenocarcinoma, and melanoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.