6 results
Primary: to assess the effect of intravenous (IV) ozanezumab (15 mg/kg once every 2 weeks) compared to placebo on the physical function and survival of ALS patients over a treatment period of 48-weeks.Secondary (major): other clinical outcomes,…
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: 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…
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 of the study is to demonstrate the antitumor activity of LDK378.
The purpose of the study is to investigate how quickly and to what extent flurbiprofen is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered via a FTS. Furthermore, the pharmacokinetics of FTS will be…