Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
NCT01081951 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2026-05-13
Summary
To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.
Conditions
Interventions
- DRUG
-
Tablets Oral BID
- DRUG
-
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
- DRUG
-
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
- DRUG
-
175mg/m2 iv for up to 6 cycles (18 weeks)
- DRUG
-
Drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Jane Robertson, BSc, MBCHB, MD · AstraZeneca
-
Amit Oza, MD · Princess Margaret Hospital, Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 125 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-04
- Primary Completion
- 2011-10-10
- Completion
- 2026-12-31
Countries
- United States
- Australia
- Belgium
- Canada
- Czechia
- Germany
- Italy
- Japan
- Netherlands
- Panama
- Peru
- Spain
- United Kingdom
Study Locations
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