Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
NCT04703920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-01-23
Summary
This Phase 1 dose-escalation trial is to determine the safety, tolerability and recommended phase 2 dose of talazoparib in combination with belinostat in subjects with Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer.
Conditions
- Metastatic Breast Cancer
- Metastatic Castration-resistant Prostate Cancer
- Metastatic Ovarian Carcinoma
- Metastic or Unresectable Pancreatic Adenocarcinoma
Interventions
- DRUG
-
Talazoparib
Talazoparib will be administered in increasing doses up to 1 mg orally once a day.
- DRUG
-
Belinostat
Belinostat will be administered in increasing doses up to 1000 mg/m2 IV once daily on days 1-5 of a 21-day cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Acrotech Biopharma Inc.
collaborator INDUSTRY -
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Monica Burness, M.D. · University of Michigan Rogel 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
- 2021-03-04
- Primary Completion
- 2024-12-01
- Completion
- 2025-01-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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