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NCT05803382 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT05803382: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05803382 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05803382, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Adverse events and serious adverse events will be tabulated for each dose levels. As per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Capecitabine
- PROCEDURE Biopsy Procedure
- DRUG BET Bromodomain Inhibitor ZEN-3694
Study Locations (20)
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Ohio
- University of Cincinnati Cancer Center-UC Medical Center - Cincinnati
- University of Cincinnati Cancer Center-West Chester - West Chester
Florida
- UF Health Cancer Institute - Gainesville - Gainesville
Illinois
- Memorial Hospital East - Shiloh
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05803382 shows while recruiting
NCT05803382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (85% lower).
The record links to 5 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05803382 names 20 study sites across 9 states, led by Missouri, New York, Kansas.
Frequently Asked Questions
What is clinical trial NCT05803382 about?
NCT05803382 is a clinical study titled "Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers". 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...
What is the current status of trial NCT05803382?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-08. Estimated completion is 2026-06-30.
What conditions does trial NCT05803382 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Unresectable Malignant Solid Neoplasm, Unresectable Colorectal Carcinoma.
What interventions are being tested in trial NCT05803382?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG).
Who is sponsoring clinical trial NCT05803382?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05803382 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05803382's enrollment target sits among peer trials
30 78th of 92 higher than 15 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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