51
Participants
Start Date
October 8, 2014
Primary Completion Date
March 12, 2018
Study Completion Date
August 13, 2019
Copanlisib (BAY80-6946)
"Part 1 of Cycle 1 Cycle 1 Day 1: Single i.v. dose 12mg Cycle 1 Day 15: Single i.v. dose 12 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single i.v. dose 60mg (based on Part 1 data) Cycle 1 Day 15: Single i.v. dose 60mg (based on Part 1 data)~Part 1 \& Part 2~Cycle 2 and subsequent cycles:~Day 1: Single i.v. dose of 60mg Day 8: Single i.v. dose of 60mg Day15: Single i.v. dose of 60mg"
Itraconazole
Cycle 1 Day 12: 2 x 200 mg itraconazole oral (two doses, 12 hours apart) Cycle 1 Days 13-21: 200 mg itraconazole oral, once daily in the morning
Rifampin
Cycle 1 Days 10 - 21: 600mg Rifampin oral, once daily in the morning
Copanlisib (BAY80-6946)
"Cycle 1 Day 1: Single i.v. dose 60mg Cycle 1 Day 15: Single i.v. dose 60mg~Cycle 2 and subsequent cycles:~Day 1: Single i.v. dose of 60mg Day 8: Single i.v. dose of 60mg Day15: Single i.v. dose of 60mg"
Dallas
Edmonton
Vancouver
Hamilton
Toronto
Lead Sponsor
Bayer
INDUSTRY