Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 4:19 PM
Study NCT ID:
NCT00724334
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2008-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055728', 'term': 'Primary Myelofibrosis'}], 'ancestors': [{'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C528327', 'term': 'fedratinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-02-17', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2008-07-17', 'dispFirstSubmitQcDate': '2016-02-17', 'studyFirstSubmitQcDate': '2008-07-25', 'dispFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Clinical activity and pharmacodynamics', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myelofibrosis'], 'conditions': ['Myelofibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mpdfoundation.org/', 'label': 'MPD Foundation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.', 'detailedDescription': 'SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of MF-TG101348-001 study\n* Diagnosis of myelofibrosis\n* At least 18 years of age\n\nExclusion Criteria:\n\n* Any acute or chronic medical abnormality that may increase the risk associated with study participation'}, 'identificationModule': {'nctId': 'NCT00724334', 'briefTitle': 'A Long-Term Study of the Effects of Orally Administered SAR302503 in Patients With Myelofibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis', 'orgStudyIdInfo': {'id': 'TED12015'}, 'secondaryIdInfos': [{'id': 'MF-TG101348-002', 'type': 'OTHER', 'domain': 'Targegen'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: SAR302503 (TG101348)']}], 'interventions': [{'name': 'SAR302503 (TG101348)', 'type': 'DRUG', 'description': 'orally administered, once a day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840103', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840102', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 840105', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0759', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 840106', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigational Site Number 840104', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 840101', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Ayalew Tefferi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic, Rochester, MN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}