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
Phase 2
Active, not recruiting
NCT01081951
| Condition | Ovarian Cancer |
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| Phase | Phase 2 |
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| Sponsor | AstraZeneca |
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| Status | Active, not recruiting |
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| Enrollment | 162 participants |
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| Interventions | olaparib, paclitaxel, carboplatin, paclitaxel, Drug: carboplatin |
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| Start date | Feb 4, 2010 |
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| Completion date | Oct 10, 2011 |
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| Results posted | Dec 10, 2012 |
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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.
Progression Free Survival (PFS)
Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) · months
| Olaparib/Carboplatin AUC4/Paclitaxel | 12.2 months |
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| Carboplatin AUC6/Paclitaxel | 9.6 months |
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| p-value | 0.0012 |
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| Hazard Ratio (HR) | 0.51 (95% CI 0.34–0.77) |
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Open in BENITIONS
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