Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
Study NCT ID:
NCT00412828
Status:
COMPLETED
Last Update Posted:
2015-02-19
First Post:
2006-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
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': 'C541991', 'term': 'CR011-vcMMAE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'dispFirstSubmitDate': '2015-02-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2006-12-18', 'dispFirstSubmitQcDate': '2015-02-02', 'studyFirstSubmitQcDate': '2006-12-18', 'dispFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'to evaluate the immune response to CR011-vcMMAE', 'timeFrame': 'throughout the study'}, {'measure': 'to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE', 'timeFrame': 'throughout the study'}, {'measure': 'to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Melanoma', 'CR011-vcMMAE'], 'conditions': ['Unresectable Stage III or Stage IV Melanoma']}, 'referencesModule': {'references': [{'pmid': '25267741', 'type': 'RESULT', 'citation': 'Ott PA, Hamid O, Pavlick AC, Kluger H, Kim KB, Boasberg PD, Simantov R, Crowley E, Green JA, Hawthorne T, Davis TA, Sznol M, Hwu P. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma. J Clin Oncol. 2014 Nov 10;32(32):3659-66. doi: 10.1200/JCO.2013.54.8115. Epub 2014 Sep 29.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25267741', 'label': 'Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female with age ≥ 18 years.\n* Progressive or new metastatic melanoma, stage III or IV.\n* Measurable disease by CT / MRI\n* Failure of no more than 1 line of prior cytotoxic therapy.\n* Adequate bone marrow, renal and hepatic function\n\n * Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3\n * Hemoglobin ≥ 10 g/dL (transfusion allowed)\n * Total bilirubin ≤ 1.5 x upper normal limit (UNL)\n * AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable)\n * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \\> 45 mL/min/1.73 m2\n * PT/aPTT \\< 1.5 x UNL or within therapeutic range via anti-coagulation therapy\n* Karnofsky PS ≥ 70%.\n* Estimated life expectancy \\> 3 months.\n* Signed informed consent approved IRB and ability to comply with the study or monitoring procedures.\n* Subjects with evaluable disease are eligible in dose-escalation cohorts\n\nExclusion Criteria:\n\n* Prior therapies for disease under study less than 4 weeks prior to enrollment.\n* Major surgery or trauma within 4 weeks of enrollment.\n* Active brain metastases\n* Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders.\n* History of allergic reactions to dolastatin, auristatin or compounds of similar composition.\n* Significant cardiovascular disease\n* Other malignancies\n* Pregnancy or breast feeding\n* Refusal or inability to use effective means of contraception (for men, and women with childbearing potential)\n* History of or test-positive to HIV, or hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT00412828', 'briefTitle': 'A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celldex Therapeutics'}, 'officialTitle': 'A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma', 'orgStudyIdInfo': {'id': 'CR011-CLN-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CR011-vcMMAE', 'type': 'DRUG', 'description': 'administered as an intravenous infusion of 250 mL over 90 min'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Angeles Clinic and Research Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CuraGen Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}