Phase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors
National Cancer Institute (NCI)
Summary
This phase I/II trial tests the safety, side effects, and best dose of entinostat and ZEN003694 in treating patients with solid tumors that have spread to other places in the body (advanced) or does not respond to treatment (refractory). Entinostat is in a class of drugs called histone deacetylase (HDAC) inhibitors. It may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. This trial aims to test the safety of combination therapy with entinostat and ZEN003694 in treating patients with advanced or refractory solid tumors.
Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of BET bromodomain inhibitor ZEN-3694 (ZEN003694) and entinostat in combination in patients with advanced and refractory solid tumors based on dose limiting toxicities (DLTs) of the combination of ZEN003694 and entinostat. (Phase I) II. To determine the overall response rate (ORR) of ZEN003694 and entinostat in advanced/progressive pancreatic cancer. (Phase II) SECONDARY OBJECTIVES: I. To describe the safety profile of ZEN003694 and entinostat in advanced and refractory solid tumors. (Phase I) II. To determine the progress…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a) advanced or refractory solid tumor and must meet standard requirements for treatment * For patients in Phase 2: Patients must have locally advanced, unresectable OR metastatic pancreatic cancer refractory to standard therapy * For patients with solid tumors, they must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria * For patients with solid tumors, they must have received at least one standard of care regimen for metastatic disease * Age \>= 18 years. Because no dosing or adverse event data are cur…
Interventions
- DrugBET Bromodomain Inhibitor ZEN-3694
Given PO
- ProcedureComputed Tomography
Undergo CT
- ProcedureCore Biopsy
Undergo core needle biopsy
- DrugEntinostat
Given PO
Locations (3)
- Yale UniversityNew Haven, Connecticut
- UF Health Cancer Institute - GainesvilleGainesville, Florida
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma