Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 9:34 PM
Study NCT ID:
NCT00522834
Status:
TERMINATED
Last Update Posted:
2014-03-04
First Post:
2007-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512195', 'term': 'elesclomol'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'dispFirstSubmitDate': '2014-01-31', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-31', 'studyFirstSubmitDate': '2007-08-28', 'dispFirstSubmitQcDate': '2014-01-31', 'studyFirstSubmitQcDate': '2007-08-29', 'dispFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'June 2009'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'December 2009'}, {'measure': 'Objective response rate', 'timeFrame': 'December 2009'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'December 2009'}, {'measure': 'Duration of objective response', 'timeFrame': 'December 2009'}, {'measure': 'Safety', 'timeFrame': 'December 2009'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'December 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['melanoma', 'oncology', 'Stage IV Metastatic Melanoma'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '23401447', 'type': 'DERIVED', 'citation': "O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11."}]}, 'descriptionModule': {'briefSummary': '"Elesclomol (STA-4783), N-malonyl-bis (N\'-methyl-N\'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.\n\nSubjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.\n\nOne treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin\n* ECOG performance status of \\<=2\n* Measurable disease according to modified RECIST\n* Life expectancy of greater than 12 weeks\n* LDH \\<= 2.0 x ULN\n* Clinical lab values within protocol parameters.\n* At least 18 years old and able and willing to provide informed consent to participate\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy treatment for melanoma\n* Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.\n* Presence of brain metastases\n* Presence or history (\\<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ\n* Female subjects who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT00522834', 'briefTitle': 'Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synta Pharmaceuticals Corp.'}, 'officialTitle': 'A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)', 'orgStudyIdInfo': {'id': '4783-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Elesclomol (STA-4783) in Combination With Paclitaxel', 'interventionNames': ['Drug: Elesclomol (STA-4783)']}, {'type': 'OTHER', 'label': '2', 'description': 'Paclitaxel alone', 'interventionNames': ['Drug: Paclitaxel']}], 'interventions': [{'name': 'Elesclomol (STA-4783)', 'type': 'DRUG', 'description': '213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops', 'armGroupLabels': ['1']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Winthrop P. Rockefeller Cancer Institute', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic & Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center Univ. of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Medical Center Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94503', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Redwood Regional Medical Group', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Anschutz Cancer Pavillion University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hematology Oncology, P.C.', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Pines VA Healthcare System', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami Hospital and Clinics', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology/Hematology Associates, LTD', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Specialists, S.C.', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Specialists, SC', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46526', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Goshen Center for Cancer Care', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Mary Bird Perkins Cancer Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute, Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55422', 'city': 'Robbinsdale', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hubert H. 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