5 results
The main goal of this study is the pharmacokinetic evaluation of a 30 mg and a 60 mg pulmonary administered levodopa with 2% l-leucine dry powder dose. The results gained with this study which will be used for further optimalisation and dose…
This is a placebo- and active-controlled dose-range-finding study which isalso designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twicedaily versus placebo as an adjunct therapy to L-dopa when administered to subjectswith moderate…
This is a active-controlled dose-range-finding study which is also designed to assess the efficacy and safety of preladenant 2, 5, 10 mg twice daily during long term use as an adjunct therapy to L-dopa when administered to subjects with moderate to…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
Primary Objective:Part 1:- To determine the MTD and recommended phase 2 dose (RP2D) of avapritinib.- To determine the safety and tolerability of avapritinib.Part 2:* To determine the overall response rate (ORR) by RECIST criteria at the MTD/RP2D of…