5 results
Primary Objectives:• To investigate the effects of a stable level of alcohol (0.6 g/L) on fMRI activation patterns in healthy male volunteers,• To investigate the effect of a stable level of morphine (80 nmol/L) on fMRI activation patterns in…
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),…
The main aim of the LOFIT study is to determine the (cost) effectiveness of a hospital-based dedicated LFO in comparison with usual care 12 months after participation
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…