Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00679783|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2008
Results First Posted : August 12, 2011
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma Breast Cancer||Drug: AZD2281||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open Label, Non-Randomized Study of AZD2281 in the Treatment of Patients With Known BRCA or Recurrent High Grade Serous/ Undifferentiated Tubo-Ovarian Carcinoma and in Known BRCA or Triple Negative Breast Cancer to Determine Response Rate and Correlative Markers of Response|
|Actual Study Start Date :||July 8, 2008|
|Actual Primary Completion Date :||March 26, 2010|
|Estimated Study Completion Date :||December 28, 2018|
U.S. FDA Resources
AZD2281, PARP inhibitor
Other Name: Olaparib
- Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines [ Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
- Disease Control Rate (DCR) [ Time Frame: 16 Weeks ]Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
- Duration of Response [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
- Best Percentage Change From Baseline in Tumour Size [ Time Frame: Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ]The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
- CA-125 Levels (Ovarian Cancer Patients Only) [ Time Frame: 24 weeks ]A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
- Progression Free Survival (PFS) [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ]PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.
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): NCT00679783
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Hamilton, Ontario, Canada, L8V 5C2|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal, Quebec, Canada, H2W 1T8|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Chair:||Karen Gelmon, MD||British Columbia Cancer Agency|
|Study Director:||Jane Robertson, BSc, MBCHB, MD||AstraZeneca|