4 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…
Primary Objectives:To determine the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.…
Currently, there are no curative treatment options for patients with Waldenstrom*s macroglobulinemia (WM) and there is no consensus on standard first line or relapse treatment. The proteasome inhibitor bortezomib has shown efficacy in WM, but is…