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
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|ClinicalTrials.gov Identifier: NCT01081951|
Recruitment Status : Active, not recruiting
First Posted : March 5, 2010
Results First Posted : December 10, 2012
Last Update Posted : April 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: olaparib Drug: paclitaxel Drug: carboplatin Drug: Drug: carboplatin||Phase 2|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 12, 2010|
|Actual Primary Completion Date :||October 10, 2011|
|Estimated Study Completion Date :||December 30, 2022|
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.
Tablets Oral BID
Other Name: Lynparza
175mg/m2 iv for up to 6 cycles (18 weeks)
Drug: Drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)
Active Comparator: 2
paclitaxel iv and carboplatin iv
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
Other Name: Taxol
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
- Progression Free Survival (PFS) [ 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) ]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).
- Overall Survival (OS) [ Time Frame: 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.
- Percentage Change in Tumour Size [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081951
|Study Director:||Jane Robertson, BSc, MBCHB, MD||AstraZeneca|
|Principal Investigator:||Amit Oza, MD||Princess Margaret Hospital, Canada|