7 results
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
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…
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 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…
Part A: healthy volunteers Primary objective- To determine safety and tolerability of a single dose of VB5-845D-800CW in healthy volunteers.Secondary objective- To determine the pharmacokinetics of VB5-845D-800CW by measuring fluorescence in blood…
To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo in high-risk patients with complete resection of Stage IIIA (> 1 mm metastasis), IIIB and IIIC…
Primary objectiveTo compare the effect on psoriasis symptoms of an adjustable brodalumab dosage regimen to standard brodalumab treatment in subjects with moderate-to-severe psoriasis and a body weight >=120 kg.Secondary objectives:To evaluate…