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Clinical Trials/EUCTR2008-000972-25-HU
EUCTR2008-000972-25-HUActive, not recruitingPhase 1

A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III 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

AB SCIENCE0 sites223 target enrollmentStarted: May 16, 2013Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
223
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Patient with one of the following documented mastocytosis as per WHO classification:
  • •Smouldering Systemic Mastocytosis
  • •Indolent Systemic 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):
  • •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 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 micturition per day = 8
  • •Fatigue Impact Scale total score (asthenia) = 75
  • •5. Patients with OPA > 2 (moderate to intolerable general handicap)
  • •6. ECOG = 2
  • •7. Patient with adequate organ function :
  • •Absolute neutrophils count (ANC) = 2.0 x 109/L,
  • •Haemoglobin = 10 g/dL
  • •Platelets (PTL) = 100 x 109/L
  • •AST/ALT = 3x ULN (= 5 x ULN in case of liver mast cell involvement),
  • •Bilirubin = 1.5x ULN
  • •Creatinine clearance >60mL/min (Cockcroft and Gault formula)
  • •Albumin >1 x LLN
  • •Proteinuria < 30mg/dL on the dipstick; in case of proteinuria = 1+ on dipstick, 24 hours
  • •proteinuria should be <1.5g/24 hours
  • •8. Male or female patient aged 18 to 75 years, weight > 50 kg, BMI between 18 and 35 kg/m²
  • •9. Male or female patient of child bearing potential ust agree to use two methods (one for the patient
  • •and one for the partner) of medically acceptable forms of contraception during the study and for
  • •three months after the last treatment intake. Female patients must have a negative result in the
  • •pregnancy tests at screening and baseline.
  • •10. Patient must be able and willing to comply with study visits and procedures per protocol
  • •11. Patient must understand, sign, and date the written voluntary informed consent form at the
  • •screening visit prior to any protocol-specific procedures performed
  • •12. Patient must understand the patient card and follow the patient card procedures in case of signs or
  • •symptoms of severe neutropenia or severe cutaneous toxicity during the first 2 months of
  • •13. Patient affiliated to a social security regimen
  • •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)
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. 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 leukaemia (MCL)
  • •Aggressive systemic mastocytosis (ASM)
  • •2. Previous treatment with any Tyrosine Kinase Inhibitor
  • •3. Patient presenting with cardiac disorders defined by at least one of the following conditions:
  • •Patient with recent cardiac history (within 6 months) of:
  • •- Acute coronary syndrome
  • •- Acute heart failure (class III or IV of the NYHA classification)
  • •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular
  • •fibrillation, resuscitated sudden death)
  • •Patient with cardiac failure class III or IV of the NYHA classification
  • •Patient with severe conduction disorders which are not prevented by permanent pacing
  • •(atrio-ventricular block 2 and 3, sino-atrial block)
  • •Syncope without known aetiology within 3 months
  • •Uncontrolled severe hypertension, according to the judgment of the investigator, or
  • •symptomatic hypertension
  • •4. Patient who had major surgery within 2 weeks prior to screening visit
  • •5. Vulnerable population defined as:
  • •Life expectancy < 6 months
  • •Patient with < 5 years free of malignancy, except treated basal cell skin cancer or cervical
  • •carcinoma in situ
  • •Patient with any severe and/or uncontrolled medical condition
  • •Patient with known diagnosis of human immunodeficiency virus (HIV) infection
  • •6. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol
  • •beverage consumption that would interfere with the ability to comply with the study protocol, or
  • •current or past psychiatric disease that might interfere with the ability to comply with the study
  • •protocol or give informed consent, or institutionalized by court decision
  • •7. 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
  • •8. Change in the symptomatic treatment of mastocytosis or administration of any new treatment of
  • •mastocytosis within 4 weeks prior to baseline
  • •9. Treatment with any investigational agent within 4 weeks prior to baseline

Investigators

Sponsor
AB SCIENCE

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