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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Tablets Oral BID
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
Progression Free Survival (PFS)
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).
Time frame: 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)
Overall Survival (OS)
OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive. Updated OS based on final OS analysis (DCO 31 January 2014)
Time frame: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Percentage Change in Tumour Size
The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as \[(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions\]\*100 for each patient. Imputations were used for missing data where possible.
Time frame: Week 9 (+/- 1 week)
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175mg/m2 iv for up to 6 cycles (18 weeks)
AUC4 iv for up to 6 cycles (18 weeks)
Research Site
Stanford, California, United States
Research Site
West Hollywood, California, United States
Research Site
Orlando, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Parkville, Australia
Research Site
Randwick, Australia
...and 43 more locations