Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Ovarian Cancer

In brief

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

Key facts

Study ID

NCT00753545

Run by

AstraZeneca

People needed

265

Starts

2008-08-28

Expected to finish

2023-10-12

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older, up to 130. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Research Site — San Francisco, California, United States
• Research Site — West Hollywood, California, United States
• Research Site — Sunrise, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — New York, New York, United States
• Research Site — Providence, Rhode Island, United States
• Research Site — Adelaide, Australia
• Research Site — East Bentleigh, Australia
• Research Site — Heidelberg, Australia
• Research Site — Melbourne, Australia
• Research Site — Nambour, Australia
• Research Site — Randwick, Australia
• Research Site — South Brisbane, Australia
• Research Site — Toorak Gardens, Australia
• Research Site — Innsbruck, Austria
• Research Site — Vienna, Austria
• Research Site — Wein, Austria
• Research Site — Brussels, Belgium
• Research Site — Leuven, Belgium
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Berkeley, California, United States

Full record on ClinicalTrials.gov

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