COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

October 8, 2014

Primary Completion Date

March 12, 2018

Study Completion Date

August 13, 2019

Conditions
Medical Oncology
Interventions
DRUG

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"

DRUG

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

DRUG

Rifampin

Cycle 1 Days 10 - 21: 600mg Rifampin oral, once daily in the morning

DRUG

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"

Trial Locations (5)

75230

Dallas

T6G 1Z2

Edmonton

V5Z 4E6

Vancouver

L8V 5C2

Hamilton

M5G 2M9

Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02253420 - COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients | Biotech Hunter | Biotech Hunter