ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors
NCT06161493 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2024-10-15
Summary
This Phase I, open label, dose determining study of oral niraparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with metastatic or recurrent solid cancer. Dose escalation will follow the mTPI-2/Keyboard design. Eligible patients will receive therapy until disease progression or unacceptable toxicities are experienced.
Conditions
- Ovarian Cancer
- Recurrent Solid Tumors
Interventions
- DRUG
-
ZEN003694
A bromodomain extra-terminal inhibitor (BETi) that blocks a group of proteins called bromodomain and extra-terminal (BET), which may counteract the effect of NSD3 on tumor growth.
- DRUG
-
Niraparib
An anti-cancer medication (PARP inhibitor) used for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer .
Sponsors & Collaborators
- collaborator INDUSTRY
-
Zenith Epigenetics
collaborator INDUSTRY -
Haider Mahdi
lead OTHER
Principal Investigators
-
Haider S Mahdi, MD · UPMC Magee Women's Hospital, UPMC Hillman Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-23
- Primary Completion
- 2026-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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