Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
British Columbia Cancer Agency
Conditions:
Ovarian Carcinoma
Breast Cancer
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
July 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00679783
Start Date
July 8 2008
End Date
July 20 2022
Last Update
July 12 2023
Active Locations (6)
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1
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
2
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
3
Research Site
Halifax, Nova Scotia, Canada, B3H 1V7
4
Research Site
Hamilton, Ontario, Canada, L8V 5C2