NCT02631590

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

Phase II Study of Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Carcinoma
• Gall Bladder Carcinoma
• Cholangiocarcinoma
• Gastrointestinal Tumor

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
DRUG	Gemcitabine	Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
DRUG	Copanlisib	Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.

Timeline

• Start date: 2016-07-05
• Primary completion: 2019-10-25
• Completion: 2021-03-05
• First posted: 2015-12-16
• Last updated: 2021-08-04
• Results posted: 2020-11-02

Locations

1 site across 1 country: United States