Small Cell Lung Carcinoma Clinical Trial
Official title:
An Open-label, Multi-center, Non-randomized Phase Ib Study to Investigate the Safety, Efficacy, and Pharmacokinetics of BAY 73-4506 "Regorafenib", Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
This is a multi-center, open-label, non-randomized Phase I study to define the safety
profile, maximum tolerated dose (MTD) and potential pharmacokinetic interaction of
regorafenib in combination with pemetrexed and cisplatin in patients with Stage IIIB or
Stage IV nonsquamous Non-Small Cell Lung Cancer (NSCLC) and to determine the impact of the
combined administration on the pharmacokinetics of regorafenib, pemetrexed, and cisplatin.
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.
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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