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日本におけるBRCA遺伝子変異を有するプラチナ製剤感受性再発高悪性度上皮性卵巣がん患者を対象としたオラパリブ拡大アクセスプログラム

基本情報

NCT ID
NCT03063710
ステータス
提供終了
試験のフェーズ
-
試験タイプ
拡大アクセス
目標被験者数
-
治験依頼者名
AstraZeneca

概要

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.

対象疾患

PSR Ovarian Cancer With a BRCA Mutation

介入

olaparib(DRUG)

依頼者(Sponsor)