8 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…
The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy
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…
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…
The objective is to evaluate if topical benzoyl peroxide reduces the presence of C. acnes on the skin of the shoulder compared to a topical placebo?
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 objectives of the study are to: • Assess the efficacy of 2 dose levels of COR388 HCl in Alzheimer*s disease (AD) subjects; and• Assess the safety and tolerability of 2 dose levels of COR388 HCl in AD subjects.