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

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: matching placebo

Drug: AZD2281

Study type

Interventional

Funder types

Industry

Identifiers

NCT00753545

2008-003439-18 (EudraCT Number)

D0810C00019

Details and patient eligibility

About

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

Enrollment

265 patients

Sex

Female

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).