8 results
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
Primary ObjectivesPart A:To determine the pharmacokinetics (PK) of intramuscular (IM)administrations of REGN2222Part B:To demonstrate the efficacy of REGN2222 in preventing medicallyattended respiratory syncytial virus (RSV) infections (subjects…
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 the degree of IOP lowering after trabeculectomy with adjuvant Ologen® implantation, in comparison to trabeculectomy with mitomycin-C. Secondary objectives are peroperative and postoperative complications, and postoperative…
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 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 primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy