A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
Patients will be treated INC280 and gefitinib(250mg) daily. Dose escalation for INC280 will
be performed. Each cohort for the phase IB part will consist of 3 to 6 newly enrolled
patients. A twice daily administration of INC280 may be investigated if deemed appropriate
based on emerging results from ongoing clinical trials.
Interventional
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase Ib: Frequency and characteristics of dose limiting toxicities (DLTs) to the
1 cycle= 28 days
From date of treatment until DLT, up to 52weeks
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
China: State Food and Drug Administration (SFDA)
CINC280X2202
NCT01610336
April 2012
June 2015
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