Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00584493
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2009-12-14
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Use Study for Advanced Melanoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520704', 'term': 'tremelimumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2008-05'}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-11', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Advanced Unresectable Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3671028&StudyName=Treatment%20Use%20Study%20for%20Advanced%20Melanoma.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.', 'detailedDescription': 'This is an expanded access trial that canceled prior to enrolling patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced melanoma with life expectancy of at least 6 months.\n* Melanoma must be considered unresectable.\n* Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.\n\nExclusion Criteria:\n\n* Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment.\n* History of chronic inflammatory or autoimmune disease.\n* History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.'}, 'identificationModule': {'nctId': 'NCT00584493', 'briefTitle': 'Treatment Use Study for Advanced Melanoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Treatment Use Study of CP-675,206 for Advanced Melanoma', 'orgStudyIdInfo': {'id': 'A3671028'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CP-675,206', 'type': 'DRUG', 'description': 'This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma\n\nSurvival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer Inc'}}}}