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MITO 31: Olaparib in BRCA Wild-Type Recurrent Ovarian Cancer
NCT04091204Phase 2
Key facts
- Status
- Unknown
- Start
- Jul 2019
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- olaparib
- Conditions
- ovarian cancer
01
Overview
Phase 2, open-label, single-arm trial of olaparib in ovarian cancer, sponsored by National Cancer Institute. Primary endpoint: Progression Free Survival at 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Olaparib
Olaparib 300 mg bid maintenance
03
Who it enrols
Patients with histologically diagnosed relapsed high grade ovarian cancer (including primary peritoneal and/or fallopian tube cancer) who are BRCA wild-type, platinum sensitive, and have responded to their last platinum-based chemotherapy.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Progression Free Survival 2
Worst grade toxicity per patient
Response Rate
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