5 results
Primary Objective: for each new catheter design: in-vitro establishment of time-dependent correction factors for saline-use and establish the accuracy of CO2 measurement with the capnograph. In-vivo: establish the feasibility and measurement errors…
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…
Primary:• To evaluate the clinical benefit rate (CBR) of ixabepilone Secondary:• To evaluated progression free survival (PFS)• To evaluate overall survival (OS)• To evaluate objective response rate (ORR) defined as Complete Response (CR) and Partial…
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…