FGFR（線維芽細胞増殖因子受容体）陽性の局所進行性または転移性尿路上皮癌患者におけるロガラチニブ（BAY1163877）と化学療法との比較研究

基本情報

NCT ID

NCT03410693

ステータス

完了

試験のフェーズ

第2/第3相

試験タイプ

介入

目標被験者数

175

治験依頼者名

Bayer

概要

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

対象疾患

介入

依頼者（Sponsor）

実施施設 (23)