Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 3:03 PM
Study NCT ID:
NCT01266369
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2010-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008415', 'term': 'Mastocytosis'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526575', 'term': 'masitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy on handicaps', 'timeFrame': 'week 12', 'description': 'Pruritus score at week 12 Number of flushes per week at week 12 Hamilton score at week 12 Fatigue Impact scale at week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mastocytosis', 'D816V', 'handicaps'], 'conditions': ['Mastocytosis']}, 'descriptionModule': {'briefSummary': 'The objective is to compare efficacy and safety of AB1010 at 3 or 6 mg/kg/day in treatment of patients with mastocytosis with handicap and bearing activating point mutations in the phosphotransferase domain of c-Kit such as the main mutation Asp-816-Val (D816V).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with one of the following documented mastocytosis:\n\n * Smouldering systemic mastocytosis\n * Indolent systemic mastocytosis with organomegaly\n * Indolent Systemic Mastocytosis having 2 infiltrated organs (skin and bone-marrow)\n * Any mastocytosis with in the last 6 months at least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance\n * Cutaneous Mastocytosis (CM)\n2. Skin biopsy-documented mastocytosis and evaluable disease based upon:\n\n * Histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy\n * Clinical criteria: typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma)\n3. Missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as D816V c-kit mutation in at least one infiltrated organ (bone marrow or skin)\n4. Refractory to at least one of the symptomatic treatments such as:\n\n * Anti H1\n * Anti H2\n * Proton pump inhibitor\n * Osteoclast inhibitor\n * Cromoglycate Sodium\n * Antileukotriene\n * Other therapies used for the symptomatic care\n5. Handicap defined as at least one of the following handicaps:\n\n * pruritus score ≥ 6\n * number of flushes per week ≥ 7\n * number of stools per day ≥ 4 ,\n * number of mictions per day ≥ 8 ,\n * QLQ-C30 score ≥ 60,\n * Hamilton score ≥ 10\n\nExclusion Criteria:\n\n1. Patients with one of the following mastocytosis:\n\n * Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)\n * Mast cell leukemia (MCL)\n * Aggressive systemic mastocytosis (ASM)\n2. Patient with a major surgery within 2 weeks prior to study entry\n3. No vulnerable population will be included in this study\n\n * Life expectancy \\< 6 months.\n * Patient is \\< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.\n * Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)\n * Patient has a severe and/or uncontrolled medical disease.\n * Patient has a known diagnosis of human immunodeficiency virus (HIV) infection'}, 'identificationModule': {'nctId': 'NCT01266369', 'briefTitle': 'Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Science'}, 'officialTitle': 'A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open-label, 2-parallel Group, Phase IIa Study to Compare Efficacy and Safety of AB1010 at 3 or 6 mg/kg/Day in Treatment of Patients With Mastocytosis With Handicap and Bearing Activating Point Mutations in the Phosphotransferase Domain of c-Kit Such as the Main Mutation Asp-816-Val (D816V)', 'orgStudyIdInfo': {'id': 'AB06013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'masitinib 3 mg/kg/day', 'description': 'masitinib 3 mg/kg/day', 'interventionNames': ['Drug: masitinib']}, {'type': 'EXPERIMENTAL', 'label': 'masitinib 6 mg/kg/day', 'description': 'masitinib 6 mg/kg/day', 'interventionNames': ['Drug: masitinib']}], 'interventions': [{'name': 'masitinib', 'type': 'DRUG', 'armGroupLabels': ['masitinib 3 mg/kg/day', 'masitinib 6 mg/kg/day']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Olivier Lortholary, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necker Hospital, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}