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NCT05019716 · ClinicalTrials.gov registry record · Phase 1
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
A Phase 1 study of Metastatic NUT Carcinoma and Unresectable NUT Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 5
- Study locations
NCT05019716: Recruiting Phase 1 study of Metastatic NUT Carcinoma and Unresectable NUT Carcinoma, sponsored by National Cancer Institute (NCI).
NCT05019716 is a Phase 1 study of Metastatic NUT Carcinoma and Unresectable NUT Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05019716, a Phase 1 study of Metastatic NUT Carcinoma and Unresectable NUT Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Combination therapy with ZEN003694 and etoposide and cisplatin or carboplatin and paclitaxel may be safe and effective in treating patients with NUT carcinoma.
Primary Outcome
MTD is the highest dose level at which \< 33% of the cohort experience a dose limiting toxicity in the first cycle.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Cisplatin
- PROCEDURE Biopsy Procedure
- DRUG BET Bromodomain Inhibitor ZEN-3694
Study Locations (5)
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Massachusetts
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05019716 shows while recruiting
NCT05019716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 3 conditions, with Metastatic NUT Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05019716 lists 5 locations in 4 states (California, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05019716 about?
NCT05019716 is a clinical study titled "Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma". This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood character...
What is the current status of trial NCT05019716?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-07-13. Estimated completion is 2026-06-30.
What conditions does trial NCT05019716 study?
This clinical trial studies the following conditions: Metastatic NUT Carcinoma, Unresectable NUT Carcinoma, Advanced NUT Carcinoma.
What interventions are being tested in trial NCT05019716?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Cisplatin (DRUG), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG).
Who is sponsoring clinical trial NCT05019716?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05019716 being conducted?
This trial has 5 study locations across California, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05019716's enrollment target sits among peer trials
36 1211th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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