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
Sponsor study identifier
interventional
99
1 country
6
Study Start
July 8, 2008
Actual (reported)Primary Completion
March 26, 2010
Actual (reported)Study Completion
July 20, 2022
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2008
Actual (reported)May 19, 2008
Actual (reported)July 8, 2008
Actual (reported)March 26, 2010
Actual (reported)August 12, 2011
Actual (reported)July 20, 2022
Actual (reported)Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines
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.
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.
Disease Control Rate (DCR)
16 Weeks
Duration of Response
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Halifax, Nova Scotia, B3H 1V7, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Montreal, Quebec, H2X 3E4, Canada
Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.
Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.
Karen Gelmon, MD
British Columbia Cancer Agency
Jane Robertson, BSc, MBCHB, MD
AstraZeneca
99 participants (actual enrollment reported by the registry).
First Submitted
May 15, 2008
First Posted
Best Percentage Change From Baseline in Tumour Size
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.
CA-125 Levels (Ovarian Cancer Patients Only)
24 weeks
Progression Free Survival (PFS)
RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral
Contact the study team to confirm eligibility.
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. doi: 10.1016/S1470-2045(11)70214-5. Epub 2011 Aug 19.
May 19, 2008
Study Start
July 8, 2008
Actual (reported)Primary Completion
March 26, 2010
Actual (reported)Study Completion
July 20, 2022
Actual (reported)Last Updated
July 12, 2023
Results First Posted
August 12, 2011
Record last verified: 2023-07
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Source: ClinicalTrials.gov.
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