Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-26 @ 2:29 PM
Study NCT ID:
NCT00827203
Status:
SUSPENDED
Last Update Posted:
2009-03-09
First Post:
2009-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-06', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors', 'timeFrame': 'Jan 2011'}, {'measure': 'To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion', 'timeFrame': 'Jan 2011'}], 'secondaryOutcomes': [{'measure': 'To inform dose selection for future study using a once-a-week schedule', 'timeFrame': 'Jan 2011'}, {'measure': 'To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable', 'timeFrame': 'Jan 2011'}, {'measure': 'To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense', 'timeFrame': 'Jan 2011'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'metastatic', 'Elesclomol Sodium', 'tumor', 'Advanced solid tumors that are metastatic and unresectable'], 'conditions': ['Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Males and females at least 18 years of age\n* Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable\n* Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy\n* Acceptable organ and marrow function during the Screening Period as defined by the protocol.\n* Reliable venous access suitable for weekly study drug infusions\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria\n\n* Pregnant or breast-feeding women\n* Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study\n* Primary brain tumors or active brain metastases\n* Treatment with chronic immunosuppressants\n* Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration'}, 'identificationModule': {'nctId': 'NCT00827203', 'briefTitle': 'A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synta Pharmaceuticals Corp.'}, 'officialTitle': 'A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors', 'orgStudyIdInfo': {'id': '4783-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort', 'interventionNames': ['Drug: Elesclomol Sodium']}], 'interventions': [{'name': 'Elesclomol Sodium', 'type': 'DRUG', 'description': 'Chemotherapy agent', 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mayo Clinic'}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synta Pharmaceuticals Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Hynds, Clinical Trials Manager', 'oldOrganization': 'Synta Pharmaceuticals'}}}}