Study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Indolent with handicap

Phase 1

• Conditions: Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicaps; MedDRA version: 20.0Level: PTClassification code 10026891Term: MastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000972-25-CZ
• Lead Sponsor: AB SCIENCE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-01
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patient with one of the following documented mastocytosis as per WHO classification:
- Smouldering Systemic Mastocytosis
- Indolent Systemic Mastocytosis
- Cutaneous Mastocytosis
2. 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
3. Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy used at optimized dose (refer to table 2):
- Anti H1
- Anti H2
- Proton pump inhibitor
- Osteoclast inhibitor
- Cromoglycate Sodium
- Antileukotriene
4. Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and asthenia:
- pruritus score = 6
- number of flushes per week = 7
- Hamilton rating scale (depression) = 10
- number of stools per day = 4 ,
- number of mictions per day = 8 ,
- Fatigue Impact Scale total score (asthenia) = 40
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient with one of the following mastocytosis:
- Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)
- Mast cell leukemia (MCL)
- Aggressive systemic mastocytosis (ASM)
2. Previous treatment with any Tyrosine Kinase Inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified