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

Condition(s) studied

Investigational drug(s) / intervention(s)

olaparib: Tablets Oral BID

paclitaxel: 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

carboplatin: AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

paclitaxel: 175mg/m2 iv for up to 6 cycles (18 weeks)

Drug: carboplatin: AUC4 iv for up to 6 cycles (18 weeks)

Study 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.

Eligibility

Primary outcome measure(s)

• 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)
  PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).

Trial sites (53)

+ 13 more sites — see the full list on the official registry below.