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Report for Clinical Trial NCT00814073

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Placebo-controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib at 6 mg/kg/Day to Placebo in Treatment of Patients With Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis With Handicap

The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.

NCT00814073 Indolent Systemic Mastocytosis
MeSH: Mastocytosis Mastocytosis, Systemic
HPO: Mastocytosis

3 Interventions

Name: Masitinib

Description: Masitinib 6 mg/kg/day

Type: Drug

Masitinib Masitinib & Masitinib & BSC

Name: Placebo

Description: Matching placebo

Type: Drug

Placebo Placebo & Placebo & BSC

Name: Best Supportive Care

Description: Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglicate, antidepressants, leukotriene antagonists, interferon-alpha, 2-CdA, and corticosteroids.

Type: Other

Masitinib Masitinib & Masitinib & BSC Placebo Placebo & Placebo & BSC

Primary Outcomes

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

Secondary Outcomes

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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 D816V

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 ---

HPO Nodes

Genes 8