Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

Official Title
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A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer

Conditions
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Ovarian Neoplasm

Intervention / Treatment
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* Drug: KU-0059436 (AZD2281)(PARP inhibitor)
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced ovarian cancer with positive BRCA1 or BRCA2 status Failed at least one prior chemotherapy In investigators opinion, no curative standard therapy exists Measurable disease Exclusion Criteria: Brain metastases Less than 28 days since last treatment used to treat the disease Considered a poor medical risk due to a serious uncontrolled disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KU-0059436 (AZD2281) 100 mg BID<br> | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>* Other names: Olaparib;|
| Experimental: KU-0059436 (AZD2281) 400 mg BID<br> | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit (CB) | Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks) | End of study | 
| Duration of Response | Duration of response to olaparib | End of study | 
| Best Percentage Change in Tumour Size | The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions). | End of study | 
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced ovarian cancer, Poly(ADP ribose) polymerases, KU-0059436, AZD2281, BRCA1 protein, BRCA2 protein