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

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05803382
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Stage IV Colorectal Cancer AJCC v8
  • Unresectable Colorectal Carcinoma
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BET Bromodomain Inhibitor ZEN-3694 — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Capecitabine — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Nov 8, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ZEN003694, capecitabine)
    Patients receive ZEN003694 PO QD and capecitabine PO BID 2 weeks on, 1 week off during each treatment cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI, PET/CT, and collection of blood samples throughout the trial. Patients may also undergo biopsies during screening and while on the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after last dose ]

Locations (22)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UF Health Cancer Institute - GainesvilleGainesvilleFlorida32610
Site Public Contact
[email protected]
352-273-8010
Thomas J. George (PRINCIPAL_INVESTIGATOR)
Memorial Hospital EastShilohIllinois62269-
University of Kansas Clinical Research CenterFairwayKansas66205
Site Public Contact
[email protected]
913-588-3671
Joaquina C. Baranda (PRINCIPAL_INVESTIGATOR)
University of Kansas Cancer CenterKansas CityKansas66160
Site Public Contact
[email protected]
913-588-3671
Joaquina C. Baranda (PRINCIPAL_INVESTIGATOR)
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205
Site Public Contact
[email protected]
913-588-3671
Joaquina C. Baranda (PRINCIPAL_INVESTIGATOR)
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Montefiore Medical Center - Moses CampusThe BronxNew York10467
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center-Einstein CampusThe BronxNew York10461
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461
Site Public Contact
[email protected]
718-379-6866
Chaoyuan Kuang (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-UC Medical CenterCincinnatiOhio45219
Site Public Contact
[email protected]
513-584-7698
Davendra P. Sohal (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer Center-West ChesterWest ChesterOhio45069
Site Public Contact
[email protected]
513-584-7698
Davendra P. Sohal (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Susanna V. Ulahannan (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Anwaar Saeed (PRINCIPAL_INVESTIGATOR)
Vanderbilt Breast Center at One Hundred OaksNashvilleTennessee37204
Site Public Contact
800-811-8480
Kristen K. Ciombor (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Site Public Contact
800-811-8480
Kristen K. Ciombor (PRINCIPAL_INVESTIGATOR)

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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUF Health Cancer Institute - Gainesville· Gainesville, FLMemorial Hospital East· Shiloh, ILUniversity of Kansas Clinical Research Center· Fairway, KSUniversity of Kansas Cancer Center· Kansas City, KS

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