RecruitingMetastatic Colorectal CarcinomaMetastatic Malignant Solid NeoplasmStage IV Colorectal Cancer AJCC v8

Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers

Eligible age

18+ yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ 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 or capecitabine
✓ Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
✓ Patients must have measurable disease
✓ Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with capecitabine in patients \< 18 years of age, children are excluded from this study
✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky \>= 60%)
✓ Availability of archival tumor tissue at the time of patient enrollment for molecular profiling studies

You may not qualify if…

✕ Previous treatment with BET inhibitors
✕ History of inability to tolerate capecitabine at the projected treatment dose on this trial
✕ Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
✕ Treatment for HIV, hepatitis B or hepatitis C only if this interferes with the current treatment (e.g. through drug-drug interactions)
✕ Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication
✕ Hepatic tumor burden \> 30% or peritoneal carcinomatosis
✕ Untreated/uncontrolled central nervous system (CNS) disease
✕ Known dihydropyrimidine dehydrogenase (DPD) deficiency