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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

This study is ongoing, but not recruiting participants.
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
History of Changes

May 15, 2008
March 28, 2012
July 2008
March 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Objective Response Rate as evaluated according to RECIST guidelines; evidence of activity in both tumour types ie CA-125 for ovarian cancer
Complete list of historical versions of study NCT00679783 on ClinicalTrials.gov Archive Site
  • Disease Control Rate (DCR) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.
  • length of time to disease progression
  • Overall Survival
  • Safety and tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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

This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Carcinoma
  • Breast Cancer
Drug: AZD2281
PARP inhibitor
Other Name: Olaparib
Experimental: 1
AZD2281, PARP inhibitor
Intervention: Drug: AZD2281
Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, Huntsman D, Clemons M, Gilks B, Yerushalmi R, Macpherson E, Carmichael J, Oza A. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol. 2011 Sep;12(9):852-61. Epub 2011 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
91
December 2012
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
  • Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
  • Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
  • Performance status of no more than 2.

Exclusion Criteria:

  • Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
  • Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00679783
D0810C00020
No
AstraZeneca
AstraZeneca
British Columbia Cancer Agency
Study Chair: Karen Gelmon, MD British Columbia Cancer Agency
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
AstraZeneca
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP