Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 1:39 PM
Study NCT ID:
NCT00998751
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2009-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526575', 'term': 'masitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-08', 'studyFirstSubmitDate': '2009-10-19', 'studyFirstSubmitQcDate': '2009-10-19', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST)', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'until disease progression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cKIT inhibitor', 'GIST'], 'conditions': ['Gastro-intestinal Stromal Tumours']}, 'referencesModule': {'references': [{'pmid': '20211560', 'type': 'RESULT', 'citation': 'Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients, age \\>18\n* Life expectancy \\> 6 months\n* Histological proven, metastatic, or locally advanced and non-operable, non- pre-treated GIST.\n* Patients having never received any tyrosine kinase inhibitor, including as adjuvant therapy\n* C-Kit (CD117) positive tumors detected immuno-histochemically\n* Measurable tumor lesions with longest diameter \\>20 mm using conventional techniques or \\>10 mm with spiral CT scan\n\nExclusion Criteria:\n\n* Documented allergy to the similar drug of AB1010\n* Inadequate organ function\n* Patients with a history of any other malignancy'}, 'identificationModule': {'nctId': 'NCT00998751', 'briefTitle': 'Masitinib in Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AB Science'}, 'officialTitle': 'Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)', 'orgStudyIdInfo': {'id': 'AB04016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'masitinib (AB1010)', 'description': 'oral masitinib 7.5 mg/kg/day', 'interventionNames': ['Drug: oral masitinib']}], 'interventions': [{'name': 'oral masitinib', 'type': 'DRUG', 'otherNames': ['AB1010'], 'description': '7.5 mg/kg/day', 'armGroupLabels': ['masitinib (AB1010)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Villejuif', 'country': 'France', 'facility': 'Lecesne', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}