Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

April 30, 2014

Conditions
Neoplasms
Interventions
DRUG

Copanlisib + Refametinib (BAY86-9766)

Copanlisib will be administered as an IV infusion weekly for 3 weeks in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 4 of Cycle 1.

DRUG

Copanlisib + Refametinib (BAY86-9766)

Copanlisib will be administered as an IV infusion weekly in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.

Trial Locations (8)

29605

Greenville

75702

Tyler

77030

Houston

79106

Freiburg im Breisgau

85260

Scottsdale

89169

Las Vegas

98684

Vancouver

3015 CE

Rotterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01392521 - Phase Ib Study of PI3(Phosphoinositol 3)-Kinase Inhibitor Copanlisib With MEK (Mitogen-activated Protein Kinase) Inhibitor Refametinib (BAY86-9766) in Patients With Advanced Cancer | Biotech Hunter | Biotech Hunter