"Determination of Safety, Efficacy, and Pharmacokinetics of Regorafenib Combined With Pemetrexed and Cisplatin in Patients With Nonsquamous Non-Small Cell Lung Cancer"

PHASE1TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Small Cell Lung Carcinoma
Interventions
DRUG

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.

DRUG

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.

Trial Locations (4)

10065

New York

27599

Chapel Hill

06519

New Haven

89135-3011

Las Vegas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY