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 : January 7, 2021
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | February 26, 2010 | ||||||||||||||
First Posted Date ICMJE | March 5, 2010 | ||||||||||||||
Results First Submitted Date ICMJE | November 12, 2012 | ||||||||||||||
Results First Posted Date ICMJE | December 10, 2012 | ||||||||||||||
Last Update Posted Date | January 7, 2021 | ||||||||||||||
Actual Study Start Date ICMJE | February 4, 2010 | ||||||||||||||
Actual Primary Completion Date | October 10, 2011 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE |
Progression free survival [ Time Frame: Event driven primary outcome, approx. 19 months after recruitment is open ] | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | 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 | ||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||
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 Provided | ||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
162 | ||||||||||||||
Original Estimated Enrollment ICMJE |
150 | ||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||||||||||
Actual Primary Completion Date | October 10, 2011 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 125 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Czechia, Germany, Italy, Japan, Netherlands, Panama, Peru, Spain, United Kingdom, United States | ||||||||||||||
Removed Location Countries | Czech Republic | ||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT01081951 | ||||||||||||||
Other Study ID Numbers ICMJE | D0810C00041 | ||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | AstraZeneca | ||||||||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||||||||||
Verification Date | November 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |