RecruitingPhase 1Phase 2NCT05019716

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 the Bromodomain Inhibitor ZEN003694 in Combination With Platinum-based Chemotherapy in Patients With NUT Carcinoma


Sponsor

National Cancer Institute (NCI)

Enrollment

36 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, and others for people with advanced nut carcinoma, metastatic nut carcinoma, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBET Bromodomain Inhibitor ZEN-3694

Given PO

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

DRUGEtoposide

Given IV

PROCEDUREImaging Procedure

Undergo imaging scans

DRUGPaclitaxel

Given IV


Locations(5)

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05019716


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