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),…
In this study, we will investigate how quickly and to what extent CKD 506 is absorbed, transported, and eliminated from the body. In addition, we will evaluate a possible interaction between CKD 506 and midazolam. We will do this by investigating…
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…
To study the technical performance and safety of the CARTBox-CA software for identification of scar-related substrate in patients. Secondary, to explore the usability of image-guided scar-related substrate mapping using CARTBox-CA software with a…
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…