Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With Solid Tumors
National Cancer Institute (NCI)
Summary
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. 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. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.
Description
PRIMARY OBJECTIVE: I. To determine the safety and tolerability, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BET bromodomain inhibitor ZEN-3694 (ZEN003694 \[ZEN-3694\]) in combination with capecitabine in patients with solid tumors. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity of ZEN003694 (ZEN-3694) in combination with capecitabine. II. To determine the pharmacokinetics (PK) of ZEN003694 (ZEN-3694) in combination with capecitabine. III. To determine the pharmacodynamics (PD) of ZEN003694 (ZEN-3694) in combination with capecitabine (death recep…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine * Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy * Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on standard therapies which would have included 5-FU…
Interventions
- DrugBET Bromodomain Inhibitor ZEN-3694
Given PO
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugCapecitabine
Given PO
- ProcedureComputed Tomography
Undergo CT and PET/CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Locations (22)
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- UF Health Cancer Institute - GainesvilleGainesville, Florida
- Memorial Hospital EastShiloh, Illinois
- University of Kansas Clinical Research CenterFairway, Kansas
- University of Kansas Cancer CenterKansas City, Kansas