NCT02631590View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 5, 2016

Primary Completion Date

October 25, 2019

Study Completion Date

March 5, 2021

Conditions
Biliary CarcinomaGall Bladder CarcinomaCholangiocarcinomaGastrointestinal Tumor
Interventions
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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

Bayer
All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER