10 results
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
Primary To determine the efficacy of REG1 compared to bivalirudin in patients with coronary artery disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) for preventing the composite of death, nonfatal myocardial infarction, nonfatal…
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 primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
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 objective: To determine the effect of obesity (BMI *35 kg/m2) on the pharmacokinetics, including oral bioavailability of fluconazole.Secondary objective: To develop an optimal dosing regimen for obese patients.