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Phase II study of Copanlisib (BAY 80-6946) in Combination with Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
The purpose of this study is to see if an experimental drug, called copanlisib is effective and safe in treating adult participants with cholangiocarcinoma, when used in combination with gemcitabine and cisplatin.
Primary Objective -To determine progression free survival (PFS) at 6 months in patients with advanced cholangiocarcinoma receiving copanlisib in combination with gemcitabine and cisplatin. Secondary Objectives - To determine response rate, PFS and overall survival (OS) in patients with advanced cholangiocarcinoma receiving copanlisib in combination with gemcitabine and cisplatin. - To determine the safety and tolerability of the combination regimen of copanlisib, gemcitabine, and cisplatin. Exploratory Objectives - To explore potential correlations between PTEN and clinical outcome -To explore potential correlation between an Illumina custom cancer next generation targeted sequencing of 26 genes including PI3K, BRAF, and RAS (NRAS and KRAS) and clinical outcome