Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Indolent Systemic Mastocytosis

In brief

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

Key facts

Study ID

NCT00814073

Run by

AB Science

People needed

135

Starts

2008-12-01

Expected to finish

2015-11-01

Last updated by the study team

2019-12-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Davis Health System , Department of Dermatology — Sacramento, California, United States
• MD Anderson Cancer Centre — Houston, Texas, United States
• CHU d'Amiens — Amiens, France
• Hôpital Avicenne — Bobigny, France
• CHU de Brest — Brest, France
• CHU de Caen — Caen, France
• CHU Clermont Ferrand — Clermont-Ferrand, France
• Hôpital Claude Huriez — Lille, France
• CHU Dupuytren — Limoges, France
• Hôpital Ambroise Paré — Marseille, France
• Hôpital Nord — Marseille, France
• Hôpital Central — Nancy, France
• CHU Hôtel Dieu — Nantes, France
• Hôpital l'Archet II — Nice, France
• Hôpital Necker — Paris, France
• Hôpital Tenon — Paris, France
• CHU Lyon Sud — Pierre-Bénite, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France
• CHU Milétrie — Poitiers, France
• CHU Hôpital Sud — Rennes, France
• CHU de Saint-Etienne — Saint-Etienne, France
• Hôpital Purpan — Toulouse, France
• Hôpital Bretonneau — Tours, France
• Hôpital des Hauts Clos — Troyes, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.