Status:
COMPLETED
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis
Lead Sponsor:
AB Science
Conditions:
Indolent Systemic Mastocytosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
Detailed Description
This was a prospective, multicenter, randomized, placebo-controlled, parallel-group, phase 3 study, conducted in 15 countries, evaluating the efficacy and safety of masitinib (6 mg/kg/day administered...
Eligibility Criteria
Inclusion
- Patient with one of the following documented mastocytosis as per WHO classification: Smouldering Systemic Mastocytosis, Severe Indolent Mastocytosis
- Patient with documented mastocytosis and evaluable disease based upon histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin and/or bone marrow biopsy
- Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy used at optimized dose: Anti H1, Anti H2, Proton pump inhibitor, Osteoclast inhibitor, Cromoglycate Sodium, Antileukotriene
- Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and fatigue: pruritus score ≥ 9, number of flushes per week ≥ 8, Hamilton rating scale for depression (HAMD-17) score ≥ 19, number of stools per day ≥ 4, number of mictions per day ≥ 8, Fatigue Impact Scale total score (asthenia) ≥ 75
- Patients with OPA ≥ 2 (moderate to intolerable general handicap)
- ECOG ≤ 2
- Patient with adequate organ function
Exclusion
- Patient with one of the following mastocytosis: Cutaneous Mastocytosis, Not documented Smouldering Systemic Mastocytosis or Indolent Systemic Mastocytosis, Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM)
- Previous treatment with any Tyrosine Kinase Inhibitor
- Patient with recent cardiac history of: Acute coronary syndrome, Acute heart failure, Significant ventricular arrhythmia; patient with cardiac failure class III or IV; Syncope without known aetiology within 3 months, uncontrolled severe hypertension.
- Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment
- Change in the symptomatic treatment of mastocytosis or administration of any new treatment of mastocytosis within 4 weeks prior to baseline
- Treatment with any investigational agent within 4 weeks prior to baseline
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00814073
Start Date
December 1 2008
End Date
November 1 2015
Last Update
December 3 2019
Active Locations (24)
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1
UC Davis Health System , Department of Dermatology
Sacramento, California, United States, 95816
2
MD Anderson Cancer Centre
Houston, Texas, United States, 77030
3
CHU d'Amiens
Amiens, France
4
Hôpital Avicenne
Bobigny, France