5 results
Primary Objective: To study which test or which combination of tests has the best predictive value at baseline level for a positive effect of the ITB test-infusion, rated by the patient on the Patient-Global Impression of Change (P-GIC). Secondary…
Primary ObjectiveTo evaluate the efficacy of lumacaftor/ivacaftor combination therapy (LUM/IVA) in subjects with cystic fibrosis (CF) 12 years of age and older who have at least one A455E mutation.Other Objectives* To explore the association between…
Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…
In this study, we want to investigate the effect of the change in co-medication from lumacaftor to tezacaftor on the kinetics and exposure levels of ivacaftor described by the through concentrationsPrimary Objective: - the through concentration of…
Phase I partPrimary:* Determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D).Secondary:* Safety and tolerability, * ORR, duration of response (DOR), disease control rate (DCR), progression free survival (PFS) and time to…