Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

December 31, 2016

Conditions
Neoplasms
Interventions
DRUG

BAY1125976

Oral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities

DRUG

BAY1125976

Oral administration twice daily. Starting dose is 40mg twice daily and will be escalated depending on any dose-limiting toxicities

DRUG

BAY1125976

Oral administration of the defined MTD which shows optimal safety, PK profile, PD target inhibition and preliminary efficacy (once daily or twice daily) in different patient groups

Trial Locations (7)

9007

Sankt Gallen

63110

St Louis

69120

Heidelberg

77030

Houston

90404

Santa Monica

94805

Villejuif

02215

Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY