Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epitheli… (NCT03063710) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan
Japan
Plain-language summary
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.
Who can participate
Age range18 Years – 130 Years
SexFEMALE
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Patients must be a permanent resident in Japan and ≥ 18 years of age. For patients aged under 20 years, written informed consent should be obtained both from the patient and his/her legal representative.
✓. Female patients with histologically diagnosed high grade epithelial ovarian cancer
✓. Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious from germline or a tumour specimen, prior to provision of informed consent
✓. Patients who have received at least 2 previous lines of platinum containing therapy prior to assignment to the study
✓. For the chemotherapy course prior to assignment to the study (except (b)):
✓. For the last chemotherapy course immediately prior to assignment to the study
✓. Pre-treatment CA-125 measurements must meet criterion specified below:
Exclusion criteria
✕. BRCA1 and/or BRCA2 mutations that are considered to be non detrimental
✕. Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to assignment to the study