4 results
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…
The main objective of the study is to determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy. Secondary objectives are to assess pulmonary toxicity by…
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…
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.