Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2008-000972-25-CZ |
Date of registration:
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01/12/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Indolent with handicap
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Scientific title:
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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 |
Date of first enrolment:
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13/01/2010 |
Target sample size:
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200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000972-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Bulgaria
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Czech Republic
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France
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Germany
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Greece
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Hungary
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India
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Italy
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Latvia
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Poland
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Russian Federation
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Slovakia
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Project Director
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Address:
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3 avenue George V
75008
PARIS
France |
Telephone:
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33147206240 |
Email:
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paul.gineste@ab-science.com |
Affiliation:
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AB Science |
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Name:
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Clinical Project Director
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Address:
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3 avenue George V
75008
PARIS
France |
Telephone:
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33147206240 |
Email:
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paul.gineste@ab-science.com |
Affiliation:
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AB Science |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicaps MedDRA version: 20.0
Level: PT
Classification code 10026891
Term: Mastocytosis
System Organ Class: 10005329 - Blood and lymphatic system disorders
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Intervention(s)
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Product Name: AB1010 Tablets Product Code: AB1010 Tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: Masitinib mesylate CAS Number: 790-299-79-5 Current Sponsor code: AB1010 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 24
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Main Objective: The objective is to compare the safety and efficacy of masitinib to placebo in patients with indolent mastocytosis with handicap.
Primary endpoint: ? Responder rate at week 24
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Secondary Objective: Secondary endpoints: ? Response in at least two out of three variables among pruritus, flushes, depression or asthenia, at week 12 and week 24 ? Responder rate at week 12 ? Pruritus score at week 12 and week 24 ? Number of flushes per week at week 12 and week 24 ? Hamilton score at week 12 and week 24 ? Fatigue Impact Scale at week 12 and week 24 ? Number of mictions per day at week 12 and week 24 ? Number of stools per day at week 12 and week 24 ? QLQ-C30 scores at week 12 and week 24 ? Overall Patient Assessment (OPA) at week 12 and week 24 ? AFIRMM V2 score at week 12 and week 24 ? Percentage of patient without handicap at week 12 and 24 ? Mast cell infiltration in the skin or bone marrow at week 24 ? Serum tryptase level at week 24 Safety profile of masitinib: Occurrence of Adverse Events, vital signs, EKG, Chest X-Ray, cardiac ultrasonography and biological parameters.
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Primary end point(s): Primary variable: Responder rate A patient is classified as responder if he/she presents an improvement of = 50% in at least one handicap, handicap being defined as a score above the cut in any of the 4 variables: - pruritus score = 6, - number of flushes per week = 7, - Hamilton score = 10, - Fatigue Impact Scale score = 40. Any patient with a worsening of more than 50% of any handicap, and/or with emergence of a new handicap with an increase of more than 50% from baseline, will be considered a non responder
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Secondary Outcome(s)
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Secondary end point(s): - Response in at least two out of three variables among pruritus, flushes, depression or asthenia, at week 12 and week 24
- Responder rate at week 12
- Pruritus score at week 12 and week 24
- Number of flushes per week at week 12 and week 24
- Hamilton rating scale for depression score at week 12 and week 24
- Fatigue Impact Scale at week 12 and week 24
- Number of micturitions per day at week 12 and week 24
- Number of stools per day at week 12 and week 24
- QLQ-C30 scores at week 12 and week 24
- Overall Patient Assessment (OPA) at week 12 and week 24
- AFIRMM V2 score at week 12 and week 24
- Percentage of patient without handicap at week 12 and 24
- Mast cell infiltration in the skin or bone marrow at week 24
- Serum tryptase level at week 24
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Timepoint(s) of evaluation of this end point: Week 12 and 24
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Secondary ID(s)
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2008-000972-25-FR
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AB06006
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Source(s) of Monetary Support
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AB Science
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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