3 results
Primary objective: Estimate the MTD and/or RDE of LDK378 as a single agent when administered orally to pediatric patients with ALK-activated tumors in the fasted and in fed stateSecondary objectives: Objective 1: Characterize the safety and…
The primary objective is to assess the relative bioavailability of TMC207 after single-dose administration of 100 mg of TMC207 as water dispersible tablets or granules using a 100-mg tablet formulation as the reference, with and without food.
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…