Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients
PSR ovarian cancer with a BRCA mutation
18 Years - 130 Years
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verified 01 May 2018 by AstraZeneca
This is a single-arm, open label, expanded access program to provide access to olaparib tablets for relapsed high-grade epithelial ovarian cancer patients (including patients with primary peritoneal and / or fallopian tube cancer) with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious [known or predicted to be detrimental/lead to loss of function]) who have responded following platinum based chemotherapy. Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met.
Primary Objective: To provide expanded access to olaparib tablets for use as maintenance monotherapy in BRCA mutated platinum sensitive relapsed (PSR) high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. Secondary Objective: Not applicable Safety Objective: To collect the individual safety data of olaparib maintenance monotherapy in BRCA mutated PSR high grade epithelial ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. When the number of enrolled patients is not enough (<5 patients), only listings of safety data will be prepared. On the other hand, if the number is sufficient (>=5 patients), summaries of safety data will be prepared using descriptive statistics. Target subject population Patients with PSR high-grade epithelial ovarian cancer with a BRCA mutation (this includes any patients with primary peritoneal and / or fallopian tube cancer). At enrollment, patients will be in complete or partial response following completion (a minimum of 4 treatment cycles) of platinum-based chemotherapy. Patients must have completed at least 2 previous lines of platinum-based therapy (e.g., carboplatin or cisplatin) before entry to the study and must be considered platinum sensitive after the penultimate platinum-based chemotherapy. Platinum sensitive in this study is defined as disease progression greater than 6 months after completion (last dose) of the penultimate platinum chemotherapy. Patients must not have received bevacizumab during the chemotherapy course immediately prior to entry. Cytoreductive surgery prior to the end of the last chemotherapy regimen is allowed as long as it is completed before the end of the chemotherapy regimen. Patients known to have BRCA mutation/s from germline (i.e., blood) or a tumour specimen, prior to provision of informed consent can enter the study based on this result. The result must be made available to AstraZeneca. Patients that have a BRCA mutation identified can enter the study provided that all such testing has been undertaken in appropriately accredited laboratories. Duration of treatment Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria are met. Investigational product, dosage and mode of administration Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Patients will be administered study treatment orally at a dose of 300 mg twice daily. The planned dose of 300 mg twice daily will be made up of two x 150 mg tablets twice daily with 100 mg tablets used to manage dose reductions. Statistical methods Approximately 10 patients will be allowed to enter the expanded access program. No formal analysis will be performed on any data obtained. However all safety data will be summarised and tabulated for regulatory purposes only, if the number of enrolled patients is sufficient (>= 5 patients). On the other hand, if the number of patients is small (<5 patients), only listings of safety data will be prepared. If the number of enrolled patients is sufficient, data summaries will be prepared based on the Safety Analysis Set, which will consist of patients who have received at least one dose of olaparib and have at least one post baseline safety assessment.
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