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Masitinib in Mastocytosis with Handicap
NCT01266369Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2007
- Primary completion
- Nov 2007
- Sponsor
- AB Science
- Modality
- Small Molecules
- Drugs
- masitinib
- Conditions
- mastocytosis
01
Overview
Phase 2, randomised, open-label trial of masitinib in mastocytosis (2 arms), sponsored by AB Science. Primary endpoint: Efficacy on Handicaps (Pruritus, Flushes, Stools, Mictions, QLQ-C30, Hamilton) at 12 weeks. Started Feb 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
masitinib 3 mg/kg/day
masitinib 3 mg/kg/day
masitinib 6 mg/kg/day
masitinib 6 mg/kg/day
03
Who it enrols
Patients with documented mastocytosis (smouldering, indolent, or cutaneous) and handicap, refractory to symptomatic treatments, and bearing c-Kit mutations.
04
Endpoints
Primary
Efficacy on Handicaps (Pruritus, Flushes, Stools, Mictions, QLQ-C30, Hamilton)
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