NCT02418624
Completed
Phase 1
A Phase I Followed by a Randomized Phase II Trial of Two Cycles Carboplatin-Olaparib Followed by Olaparib Monotherapy Versus Capecitabine in BRCA-1 or -2 Mutated Her2 Negative Advanced Breast Cancer as First Line Treatment
Interventionscarboplatin, olaparib
Overview
- Phase
- Phase 1
- Intervention
- carboplatin, olaparib
- Conditions
- Breast Cancer
- Sponsor
- The Netherlands Cancer Institute
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.
Detailed Description
A 3+3 dose escalation trial of 2 cycles (21 days) carboplatin and olaparib combination therapy, followed by olaparib monotherapy until progression or unacceptable toxicity in patients with advanced cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose escalation
carboplatin, olaparib
Intervention: carboplatin, olaparib
Outcomes
Primary Outcomes
Maximum Tolerated Dose
Time Frame: per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks)
The dose level at which more than 1/6 patients develop a dose limiting toxicity
Secondary Outcomes
- Pharmacodynamics (PAR (Poly(ADP) ribose) activation measured with the PAR assay)(1 year)
- Objective Response Rate(1 year)
- Pharmacokinetics (area under time-concentration curve (AUC))(1 year)
Study Sites (1)
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