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
Study identifier:D0810C00020
ClinicalTrials.gov identifier:NCT00679783
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Ovarian Carcinoma
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD2281
Sex
All
Actual Enrollment
99
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 08 Jul 2008
Primary Completion Date: 26 Mar 2010
Study Completion Date: 20 Jul 2022
Study design
Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
British Columbia Cancer Agency
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 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 | Drug: AZD2281 PARP inhibitor Olaparib tablets, oral Other Name: Olaparib |
| Experimental: 2 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 | Drug: AZD2281 PARP inhibitor Olaparib tablets, oral Other Name: Olaparib |
| Experimental: 3 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 | Drug: AZD2281 PARP inhibitor Olaparib tablets, oral Other Name: Olaparib |
| Experimental: 4 Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally AZD2281, PARP inhibitor Olaparib tablets, oral | Drug: AZD2281 PARP inhibitor Olaparib tablets, oral Other Name: Olaparib |
Contacts
Investigators
Principal Investigator
Karen Gelmon
British Columbia Cancer Agency
