The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
Name: Best Supportive Care
Description: The prospectively declared primary endpoint (4R75%) was cumulative response in at least one of four severe baseline symptoms of mast cell mediator release (pruritus, flushes, depression, or asthenia). Response was defined as a 75% improvement from baseline for any of these four symptoms. Cumulative response was defined as the number of actual responses between weeks 8 and 24, divided by the total number of possible responses over the same treatment period (ie, with five scheduled visits, each patient had a maximum of five to 20 possible responses depending on the number of severe baseline symptoms).Measure: Cumulative response (4R75%) Time: 24 weeks
Description: Cumulative response in at least one of three severe baseline symptoms (pruritus, flushes, or depression)Measure: Cumulative response (3R75%) Time: 24 weeks
Description: Cumulative response in at least one of three severe baseline symptoms (pruritus or flushes)Measure: Cumulative response (2R75%) Time: 24 weeks
There is one SNP
The objective of this phase 3 study was therefore to evaluate masitinib efficacy and safety in severe systemic mastocytosis patients, with or without D816V mutation of c-Kit. --- D816V ---