6 results
Part I (single ascending dose):To evaluate the safety and tolerability of ascending single doses of DRL-17822 in healthy male subjects;To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects;To determine CETP…
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…
PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…
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…