A Phase 1 Study of the Bromodomain Inhibitor ZEN003694 in Combination With Platinum-based Chemotherapy in Patients With NUT Carcinoma

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.

Description

Eligibility

Age range

12+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  BET Bromodomain Inhibitor ZEN-3694

  Given PO

• Procedure
  Biopsy Procedure

  Undergo biopsy

• Procedure
  Biospecimen Collection

  Undergo blood sample collection

• Drug
  Carboplatin

  Given IV

• Drug
  Cisplatin

  Given IV

• Drug
  Etoposide

  Given IV

• Procedure
  Imaging Procedure

  Undergo imaging scans

Locations (5)