Clinical Trials

In preclinical and clinical trials, entinostat has exhibited a wide range of anti-tumor activity, alone or in combination with other therapies.

Breast Cancer

Study: ECOG-ACRIN E2112
Title: A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer

Study: ENCORE 601
Title: A Phase 1B/2, Open-label, Dose Escalation Study of Entinostat in Combination with a Programmed Death Receptor-1/Ligand-1 (PD1/PDL1)-Blocking Antibody in Patients with Melanoma and Non-small Cell Lung Cancer

Study: ENCORE 301
Title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Exemestane +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal Aromatase Inhibitor

Study:ENCORE 303
Title: A Phase 2, Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing

Study: NCI 8871
Title: Phase 1 and Phase 1 Trastuzumab Cohort Study of Entinostat, Lapatinib and Trastuzumab in Patients With HER2-Positive Metastatic Breast Cancer in Whom Trastuzumab Has Failed

Lung Cancer

Study: NCI 9253
Title: A Randomized Phase 2 Trial of Cytotoxic Chemotherapy With or Without Epigenetic Priming in Patients With Advanced Non-Small Cell Lung Cancer

Study: J1353
Title: A Randomized Phase 2 Study of Epigenetic Priming With Azacitidine and Entinostat or Oral Azacitidine Alone Prior to Nivolumab in Subjects With Recurrent Metastatic Non-Small Cell Lung Cancer

Study: ENCORE 401
Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase 2 Study With a Lead in Phase of Erlotinib With or Without SNDX-275 in Patients With Non-Small Cell Lung Cancer After Failure in Up to Two Prior Chemotherapeutic Regimens for Advanced Disease

Study: NCI 7759
Title: A Phase 1/2 Study of Entinostat in Combination With 5-Azacytidine in Patients With Recurrent Advanced Non-Small Cell Lung Cancer

Other Solid Tumors

Study: NCI 8265
Title: A Phase 1/2 Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma

Hematologic Malignancies

Study: ENGAGE 501
Title: A Phase 2 Multi-Center Study of Entinostat (SNDX-275) in Patients With Relapsed or Refractory Hodgkin’s Lymphoma

Study: NA 00038036
Title: A Randomized Phase 2 Trial to Simultaneously Evaluate Two Schedules of the Histone Deacetylase Inhibitor Entinostat in Combination With 5-Azacytidine (5AC, NSC 102816) in Elderly Patients With Acute Myeloid Leukemia (AML)

Study: NCI 8298
Title: A Phase 1 Study of the Histone Deacetylase Inhibitor Entinostat (SNDX-275, NSC 706995, IND#61198) Plus Clofarabine for Philadelphia Chromosome-Negative, Poor Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia in Newly Diagnosed Older Adults or in Adults With Relapsed and Refractory Disease