9
Participants
Start Date
August 31, 2010
Primary Completion Date
June 30, 2012
Study Completion Date
June 30, 2012
Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed
In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break. Pharmacokinetics of regorafenib will be assessed on Day 14 of Cycle 1 and Day 1 of Cycle 2.
Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed
In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21. Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing. Pharmacokinetics of regorafenib will be assessed on Day 21 of Cycle 1 and on Day 1 of Cycle 2.
New York
Chapel Hill
New Haven
Las Vegas
Lead Sponsor
Bayer
INDUSTRY