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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Page 1 of 27 (107 locations)

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