11 results
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 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 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.
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…
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 determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
To evaluate whether Telisotuzumab Vedotin improves response rate and survival in participants who are c-Met+ with NSCLC. For the additional monotherapy cohort :Primary objective is to evaluate the safety and tolerability of telisotuzumab vedotin…
The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse…
The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy