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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by AstraZeneca.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00679783
First received: May 15, 2008
Last updated: March 28, 2012
Last verified: March 2012
Results First Received: July 19, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Carcinoma
Breast Cancer
Intervention: Drug: AZD2281

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BRCA Positive Non-serous Ovarian Patients with non-serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer; other subtypes are grouped together as "non-serous" in this study).
BRCA Positive Serous Ovarian Patients with serous ovarian cancer who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. (Serous tumors are the most common subtype of ovarian cancer).
BRCA Negative Non-serous Ovarian Patients with non-serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Negative Serous Ovarian Patients with serous ovarian cancer who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2
BRCA Positive Non-triple Negative Breast Patients with non-Triple negative breast cancer (non-TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. Non-TNBC are cancers that have receptors for oestrogen, progesterone or Her2
BRCA Positive Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2. TNBC are cancers that don’t have receptors for oestrogen, progesterone or Her2 (Some commonly used breast cancer treatments don’t work for TNBC)
BRCA Negative Triple Negative Breast Patients with Triple negative breast cancer (TNBC) who do not have a harmful mutation in the "breast cancer genes" BRCA1 or BRCA2.
Total Total of all reporting groups

Baseline Measures
    BRCA Positive Non-serous Ovarian     BRCA Positive Serous Ovarian     BRCA Negative Non-serous Ovarian     BRCA Negative Serous Ovarian     BRCA Positive Non-triple Negative Breast     BRCA Positive Triple Negative Breast     BRCA Negative Triple Negative Breast     Total  
Number of Participants  
[units: participants]
  4     13     3     44     5     5     16     90  
Age  
[units: Year]
Mean ± Standard Deviation
  60  ± 18.7     53.7  ± 7.3     60.3  ± 12.9     61  ± 9.5     49.4  ± 20.5     44.8  ± 15.5     48.8  ± 5.5     52.9  ± 13  
Gender  
[units: Participants]
               
Female     4     13     3     44     5     5     16     90  
Male     0     0     0     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 16 Weeks ]

3.  Secondary:   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. ]

4.  Secondary:   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. ]

5.  Secondary:   CA-125 Levels (Ovarian Cancer Patients Only)   [ Time Frame: 24 weeks ]

6.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00679783     History of Changes
Other Study ID Numbers: D0810C00020
Study First Received: May 15, 2008
Results First Received: July 19, 2011
Last Updated: March 28, 2012
Health Authority: Canada: Health Canada