8 results
- To evaluate the effect of steady-state TMC278 25 mg q.d. on the steady-state pharmacokinetics of R- and S-methadone.- To evaluate the potential effect of TMC278 on the pharmacodynamic effects of methadone therapy; - To evaluate the steady state…
This study involves research and the objective of this study is to evaluate how much and how fast TMC278 is absorbed into the body after administration as these concept pediatric formulations compared to when administered as the 25 mg TMC278 tablet…
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
The primary objective is to evaluate the antitumor activity of ceritinib in patients with ALK-positive NSCLC metastatic to the brain and/or toleptomeninges based on whole body overall response rate (ORR), defined as the proportion of patients with a…
Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…
The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy.The key secondary objective is to compare Overall Survival (OS) in patients treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel…
Primary: 1. To determine the MTD and/or RDE of the combination ceritinib and nivolumab. 2. To assess the preliminary antitumor activity of the combination.Secondary: 1: To assess the safety profile of the ceritinib and nivolumab combination. 2: To…
The aim of this investigation is to investigate the performance and safety of a new baseplate comprising a protective layer, which is expected to reduce peristomal skin complications induced by output.