6 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 objectives: - To test the hypothesis that a relationship between mitochondrial oxygenation and serum lactate existsSecondary objectives:- To provide data for estimating the number of patients needed for a clinical trial to prove the above…
Primary Objective: the relation between the occurrence of CSA-AKI and the duration of peri-operative low mitoPO2 measurements (<20 mmHg). Secondary Objective:- To study the relationship between the occurrence of postoperative cognitive…
The primary objective of this study is to observe the association between age and mitoPO2 values. The secondary objective is to evaluate whether there is also an association between age and the mitoVO2 values. Further objectives are to investigate…
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…