Assessment of Efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer
- Conditions
- Platinum Sensitive Serous Ovarian CancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12609000159257
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 250
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 previous 2 chemo regimens.
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.
Previous treatment with polyadenosine 5’-diphosphoribose polymerase (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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine the efficacy (assessed by progression free survival [PFS]) of AZD2281 compared to placebo in this patient population. Progression free survival is defined as the time from randomisation (when the patient starts taking the study drug on Day 1 of study) to the earlier date of objective assessment of progression (per Response Evaluation Criteria in Solid Tumours [RECIST] criteria determined via evaluations of tumours using imaging scans) or death (by any cause in the absence of progression).[CA-125 measurements will be performed every 28 days till the patient stops taking the study drug. Radiological tumour assessments will be performed every 12 weeks for 1st 60 weeks patient is in the study and then every 24 weeks there-after till the patient has disease progression.]
- Secondary Outcome Measures
Name Time Method