Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Phase 2 Completed 24 enrolled H. Lee Moffitt Cancer Center and Research Institute Bayer · collab

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-07-05
Primary completion: 2019-10-25
Completion: 2021-03-05

Outcome

Missed primary endpoint

paper The addition of copanlisib to gemcitabine and cisplatin does not improve PFS at 6 months. PMID 33289918 ↗

Publications

Tan ES, Cao B, Kim J, Al-Toubah TE, Mehta R, Centeno BA, Kim RD. Phase 2 study of copanlisib in combination with gemcitabine and cisplatin in advanced biliary tract cancers. Cancer. 2021 Apr 15;127(8):1293-1300. doi: 10.1002/cncr.33364. Epub 2020 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Copanlisib	Small molecule	60 mg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous