Preclinical and clinical studies support the promise for entinostat as a novel epigenetic therapy to address unmet needs in solid tumors and hematologic malignancies in combination and as a single agent.
Breast Cancer
| Study: | ENCORE 301 |
| Title: | A Phase 2, Randomized, Double-Blind, Multicenter Study of Aromasin® +/- Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic ER+ Breast Cancer, Progressing on Treatment With a Non-Steroidal AI |
| Study: | ENCORE 303 |
| Title: | A Phase 2, Multicenter Study of the Effect of the Addition of Entinostat to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing |
| Study: |
ECOG E2112 |
| Title: | A Randomized Phase 3 Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Metastatic Breast Cancer |
| Study: | NCI 8597 |
| Title: | A Pilot and Phase 2 Study of Entinostat and Arimidex® in Postmenopausal
Women With Operable Triple Negative Breast Cancer to Evaluate Biomarkers and Surrogates for Response |
| Study: | NCI 8822 |
| Title: | Phase 2 Study of Entinostat and
Vidaza® in Patients With Advanced Breast Cancer |
| Study: |
NCI-2011-03222 |
| Title: | Phase 1/2 Study of Entinostat and Tykerb® in Patients With HER2-Positive
Metastatic Breast Cancer in Whom
Herceptin® Has Failed |
Lung Cancer
| Study: | ENCORE 401 |
| Title: | A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study With a Lead in Phase of Tarceva® +/- Entinostat in Patients With Non-Small Cell Lung Cancer (NSCLC) 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 Vidaza® in Patients With Recurrent Advanced Non-Small Cell Lung Cancer (NSCLC) |
| Study: | NCI 8311 |
| Title: | Randomized Phase 2 Trial of Adjuvant Combined Epigenetic Therapy With Vidaza® and Entinostat in Resected Stage 1 Non-Small Cell Lung Cancer (NSCLC) Versus Standard Care |
Other Solid Tumors
| Study: | NCI 7870 |
| Title: | A Phase 1/2 Study of High Dose Interleukin 2, Proleukin®, in Combination With Entinostat in Patients With Metastatic Renal Cell Carcinoma |
| Study: | NCI 8341 |
| Title: | A Phase 2 Study of Vidaza® and Entinostat in Patients With Metastatic Colorectal Cancer |
| Study: | NCI 8272 |
| Title: | A Phase 1 Study of Nexavar® in Combination With Entinostat in Patients With Advanced Cancers |
Hematologic Malignancies
| Study: | ENCORE 501 |
| Title: | A Phase 2 Multi-Center Study of Entinostat in Patients With Relapsed or Refractory Hodgkin's Lymphoma |
| Study: | J1093 |
| Title: | A Randomized Phase 2 Trial to Simultaneously Evaluate Two Schedules of Entinostat in Combination With Vidaza® in Elderly Patients With Acute Myeloid Leukemia (AML) |
| Study: | NCI 8298 |
| Title: | A Phase 1 Study of Entinostat Plus Clolar® for Philadelphia Chromosome-Negative, Poor Risk Acute Lymphoblastic Leukemia (ALL) or Bilineage/Biphenotypic Leukemia in Newly Diagnosed Older Adults or in Adults With Relapsed and Refractory Disease |
