Status:
COMPLETED
Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-130 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
Eligibility Criteria
Inclusion
- Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
- Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
- For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
- Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion
- Previous treatment with PARP inhibitors including AZD2281
- Patients with low grade ovarian carcinoma.
- Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
- Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
Key Trial Info
Start Date :
August 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00753545
Start Date
August 28 2008
End Date
October 12 2023
Last Update
February 3 2025
Active Locations (107)
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1
Research Site
Berkeley, California, United States, 94704
2
Research Site
San Francisco, California, United States, 94115
3
Research Site
West Hollywood, California, United States, 90048
4
Research Site
Sunrise, Florida, United States, 33027