Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial)
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT03787680
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUG300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
- AZD6738 — DRUG160 mg by mouth daily for days 1-7 of a 28-day cycle.
Study Details
The purpose of this study is to test the effectiveness (how well the drugs work), safety, and tolerability of the investigational drug combination of olaparib and AZD6738 for all patients with metastatic castration-resistant prostate cancer.
Key Dates
- Start date
- Oct 31, 2019
- Status verified
- Mar 2026
- Primary completion
- Jan 26, 2023
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 49 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 (DRPro)Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair proficient (DRPro).
- Experimental: Cohort 2 (DRDef)Patients with metastatic castration-resistant prostate cancer (mCRPC) who are DNA repair deficient (DRDef).
Primary Outcome Measure
Rate of Response (Complete Response [CR] or Partial Response [PR]) in DNA Repair Proficient (DRPro) Patients [ Time Frame: Up to 30 days after study completion (an average of 1 year) ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | - |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | - |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | - |
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