Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00189332
Status:
COMPLETED
Last Update Posted:
2008-10-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of 852A in Metastatic Cutaneous Melanoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-24', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks'}], 'secondaryOutcomes': [{'measure': 'to assess the safety of the dosage regiment over 12 weeks'}, {'measure': 'to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks'}]}, 'conditionsModule': {'keywords': ['Oncology', 'Melanoma'], 'conditions': ['Melanoma', 'Unresectable Metatstatic Cutaneous Melanoma']}, 'descriptionModule': {'briefSummary': 'Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced melanoma not responding to 1st line chemotherapy\n* Histological evidence of melanoma\n* Measurable disease according to RECIST criteria\n* ECOG performance status less than or equal to 2\n* Life expectancy 6 months or more\n* Normal organ and bone marrow function as defined by hematological and serum chemistry limits\n* Adequate contraception for females of childbearing potential\n\nExclusion Criteria:\n\n* Stage IV disease which has previously progressed during interferon treatment.\n* Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes\n* History of uncontrolled seizure disorders\n* Uncontrolled coagulation disorders.\n* History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months\n* History of uncontrolled intercurrent or chronic illness\n* Concurrent malignancies.\n* Brain metastases.\n* HIV positive.\n* Prolonged QTc interval\n* Uncontrolled intercurrent or chronic illnesses.\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00189332', 'briefTitle': 'Use of 852A in Metastatic Cutaneous Melanoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.', 'orgStudyIdInfo': {'id': '1527-852A'}}, 'armsInterventionsModule': {'interventions': [{'name': '852A', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': "Hôpital Hotel Dieu, 1, Pace de l' Hôpital,", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Ste Marguerite,Service de Dermatologie', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Hautklinik, Medizinische Einrichtungen der Heinrich-Heine - Universität Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': '(DKFZ) an der Universitäts-Hautklinik Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinik und Poliklinik für Hautkrankheiten', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitatsspital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}