Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT00635557
Status:
UNKNOWN
Last Update Posted:
2011-03-25
First Post:
2008-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522974', 'term': 'verubulin'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-24', 'studyFirstSubmitDate': '2008-03-06', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2011-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose', 'timeFrame': 'After each cohort is enrolled and all subjects have completed 1 cycle'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Cycle 1 only'}, {'measure': 'Antitumor activity', 'timeFrame': 'Screening, end of each cycle, end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recurrent', 'Relapsed', 'Glioblastoma', 'Multiforme'], 'conditions': ['Glioblastoma Multiforme']}, 'descriptionModule': {'briefSummary': 'This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven WHO Grade IV glioblastoma multiforme at time of diagnosis or relapse\n* Prior treatment with radiotherapy and temozolomide\n* Evidence of measurable recurrent or residual primary tumor by contrast-enhanced MRI\n* Be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior BCNU or CCNU)\n* Have a Performance Scale of Karnofsky \\> 60%, ECOG \\< 2 or WHO \\< 2\n* If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week\n\nExclusion Criteria:\n\n* Hypersensitivity to Cremophor EL\n* Have evidence of current/active intratumor hemorrhage by MRI\n* Have greater than second relapse\n* Have had prior treatment with platinum-based chemotherapy\n* Have cardiovascular disease\n* Have cerebrovascular disease\n* Have uncontrolled hypertension\n* Have a cardiac ejection fraction \\< 50%\n* Have Troponin-I elevated above the normal range'}, 'identificationModule': {'nctId': 'NCT00635557', 'briefTitle': 'Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myrexis Inc.'}, 'officialTitle': 'Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin', 'orgStudyIdInfo': {'id': 'MPC-6827-07-004'}, 'secondaryIdInfos': [{'id': 'MPC-6827 GBM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MPC-6827 + Carboplatin', 'type': 'DRUG', 'description': 'MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute at the University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Andrew P. Beelen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Myrexis Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myrexis Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andrew P. Beelen, MD / Sr. Director of Clinical Research', 'oldOrganization': 'Myrexis Inc.'}}}}