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
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT01081951
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 162
- Diagnosed with serous ovarian cancer
- Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment
- At least one lesion that is suitable for accurate repeated measurements
- Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment
- Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 paclitaxel paclitaxel iv and carboplatin iv 1 olaparib Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. 1 paclitaxel Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. 2 carboplatin paclitaxel iv and carboplatin iv
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months) 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)
Percentage Change in Tumour Size Week 9 (+/- 1 week) 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Edinburgh, United Kingdom