6 results
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
Primary: to assess the effect of intravenous (IV) ozanezumab (15 mg/kg once every 2 weeks) compared to placebo on the physical function and survival of ALS patients over a treatment period of 48-weeks.Secondary (major): other clinical outcomes,…
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: 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 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…