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 Objective:To compare the fate of the struts in front of the side-branch using optical coherence tomography after treatment with 1. COMBO or 2. XIENCE stent using single stent strategy with side-branch fenestration in the treatment of (a)…
The research objective is to investigate the sensitivity, specificity, and predictive values of the delirium monitor based on 4 standardized EEG electrodes who record brain activity.
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…
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…