Trials / Completed
CompletedNCT04703920
Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
A Phase 1 Dose-Escalation Trial of Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-03-04
- Primary completion
- 2024-12-01
- Completion
- 2025-01-02
- First posted
- 2021-01-11
- Last updated
- 2025-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04703920. Inclusion in this directory is not an endorsement.