Health Trials

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

ConditionsAdvanced Malignant Solid NeoplasmLocally Advanced Pancreatic CarcinomaMetastatic Pancreatic CarcinomaRefractory Malignant Solid NeoplasmRefractory Pancreatic CarcinomaStage II Pancreatic Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Pancreatic Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients who have had any anti-cancer therapy within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational products

Patients who have received radiation therapy within 21 days prior to the first dose of the investigational products

Patients who have a diagnosis of NK cell lymphoma

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia, or stable chronic grade 2 toxicities that do not overlap with presumed toxicities of entinostat or ZEN003694

Trial design

Treatments tested in this trial

  • BET Bromodomain Inhibitor ZEN-3694
  • Computed Tomography
  • Core Biopsy
  • Entinostat

Treatment groups

49 Participants
are divided into 1 treatment group

Locations

3
Yale University06520, New HavenConnecticut, United States
UF Health Cancer Institute - Gainesville32610, GainesvilleFlorida, United States
University of Oklahoma Health Sciences Center73104, Oklahoma CityOklahoma, United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov