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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: olaparib
* Drug: paclitaxel
* Drug: carboplatin
* Drug: paclitaxel
* Drug: Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 125 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: olaparib<br>* Tablets Oral BID<br>* Other names: Lynparza;Drug: paclitaxel<br>* 175mg/m2 iv for up to 6 cycles (18 weeks)<br>Drug: Drug: carboplatin<br>* AUC4 iv for up to 6 cycles (18 weeks)<br>|
| Active Comparator: 2<br>paclitaxel iv and carboplatin iv | Drug: paclitaxel<br>* 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle<br>* Other names: Taxol;Drug: carboplatin<br>* AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 9 (+/- 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poly(ADP ribose), polymerisation (PARP), Platinum sensitive, Advanced Serous Ovarian cancer, olaparib, PARP inhibitors, Platinum Sensitive Advanced Serous Ovarian Cancer