Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

Phase 2

Completed

Conditions: cancer of the ovaries
10038594

Registration Number: NL-OMON43643

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

1. Provision of voluntary obtained informed consent prior to any study specific procedures.
2. Female patients, > 18 years of age, with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer with a histology type of serous, or a serous component and who have completed at least 2 previous courses of platinum containing therapy (e.g. carboplatin or cisplatin)
3. Formalin fixed, paraffin embedded tumour sample from the cancer must be available for central testing.

Exclusion Criteria

1. Patients with low grade ovarian carcinoma.
2. Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
3. Previous treatment with PARP inhibitors including AZD2281.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PFS as evaluated by RECIST</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy: OS, best overall response, duration of response, CA-125 response<br /><br>(GCIG criteria), time to progression by CA-125 (GCIG criteria) or RECIST,<br /><br>Quality of Life (QoL) and disease related symptoms.<br /><br><br /><br>Measurement of candidate biomarkers (including but not limited to ATM,<br /><br>MRE-11, MDC1, BRCA1/2) to identify the Homologous Recombination<br /><br>Deficient subset of tumours for correlation with benefit/risk of treatment with<br /><br>AZD2281.<br /><br><br /><br>Safety: AEs, physical examination, vital signs including BP, pulse, ECG and<br /><br>laboratory findings including clinical chemistry, haematology and urinalysis.</p><br>