Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity

PHASE1CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Neoplasms
Interventions
DRUG

Regorafenib (Stivarga, BAY73-4506)

All subjects will receive regorafenib administered from Day 1 -21 at a dose of 160 mg od (4 x 40 mg tablets) followed by a 7 days break in repeating cycles of 28 days. The drug is to be taken in the morning with approximately 240 mL of water after having a low fat breakfast. Holter ECGs with triplicate measurements will automatically be obtained at specified timepoints over 24 hours on days -1 and Cycle 1, Day 21. PK samples will be drawn on Cycle 1, Day 21. PK timepoints are time-matched with Holter ECG timepoints. 24 hour urine will be collected beginning on Cycle 1, Day 21. MUGA scans will be done at screening, Cycle 2 Day 21 (after 42 doses of BAY73-4506), then every 3 cycles starting in Cycle 5, and at end of treatment.

Trial Locations (6)

37203

Nashville

48109

Ann Arbor

63110

St Louis

73104

Oklahoma City

80010

Aurora

98109

Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01339104 - Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity | Biotech Hunter | Biotech Hunter