5 results
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: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
The purpose of this study is to determine the safety and efficacy of AMG 334 compared to placebo in episodic migraine patients who havepreviously failed 2 to 4 prophylactic migraine treatments and therefore have a high unmet medical need.
Primary ObjectivesAssess whether the finger tapping task endpoints:• Differentiate between ON and OFF states in PD patients• Correlate with the MDS-UPDRS part III total score• Differentiate between placebo and levodopa/carbidopa treatmentSecondary…
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…