Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT00257205
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2005-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], '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': 'D009369', 'term': 'Neoplasms'}, {'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': 'D003606', 'term': 'Dacarbazine'}, {'id': 'C520704', 'term': 'tremelimumab'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'dispFirstSubmitDate': '2011-01-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-25', 'studyFirstSubmitDate': '2005-11-18', 'dispFirstSubmitQcDate': '2011-04-26', 'studyFirstSubmitQcDate': '2005-11-18', 'dispFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'August 2010'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '1 year'}, {'measure': 'PFS at 6 months', 'timeFrame': '6 months'}, {'measure': 'objective tumor response', 'timeFrame': '1 year'}, {'measure': 'Durable response', 'timeFrame': '6 months'}, {'measure': 'pharmacokinetics endpoints', 'timeFrame': '15 months'}, {'measure': 'pharmacogenomic endpoints', 'timeFrame': '1 year'}, {'measure': 'HQol', 'timeFrame': '1 year'}, {'measure': 'healthcare resource utilization and loss of productivity', 'timeFrame': '1 year'}, {'measure': 'human antihuman antibody response for patients in Arm A', 'timeFrame': '15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '30227886', 'type': 'DERIVED', 'citation': 'Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.'}, {'pmid': '23295794', 'type': 'DERIVED', 'citation': 'Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.\n* Serum lactic acid dehydrogenase (LDH) \\<= 2 x ULN\n* ECOG performance status of 0 or 1\n\nExclusion Criteria:\n\n* Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.\n* History of brain metastases'}, 'identificationModule': {'nctId': 'NCT00257205', 'briefTitle': 'CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma', 'orgStudyIdInfo': {'id': 'A3671009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)', 'interventionNames': ['Drug: dacarbazine', 'Drug: temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: CP-675,206']}], 'interventions': [{'name': 'dacarbazine', 'type': 'DRUG', 'description': 'decarbazine 1000 mg/m2 IV Q 21 days x 12', 'armGroupLabels': ['B']}, {'name': 'CP-675,206', 'type': 'DRUG', 'otherNames': ['anti-CTLA4 human monoclonal antibody'], 'description': 'CP-675,206 15 mg/kg IV Q 90 days x 4', 'armGroupLabels': ['A']}, {'name': 'temozolomide', 'type': 'DRUG', 'description': 'temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': 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