7 results
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
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…
This study will evaluate the effect of dose tracking in conjunction with reminder notificationsand motivational/adaptive messages over 24 weeks on treatment adherence behavior insubjects with COPD. The dose tracking is done by the Concept2 inhaler…
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…