Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-22 @ 4:44 AM
Study NCT ID:
NCT00519233
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2007-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583063', 'term': 'MK-4721'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2007-08-20', 'studyFirstSubmitQcDate': '2007-08-20', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.', 'timeFrame': '3 Months'}], 'secondaryOutcomes': [{'measure': 'The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.', 'timeFrame': '3 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HRPC', 'Advanced hormone refractory prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22020316', 'type': 'BACKGROUND', 'citation': 'Antonarakis ES, Carducci MA, Eisenberger MA, Denmeade SR, Slovin SF, Jelaca-Maxwell K, Vincent ME, Scher HI, Morris MJ. Phase I rapid dose-escalation study of AGS-1C4D4, a human anti-PSCA (prostate stem cell antigen) monoclonal antibody, in patients with castration-resistant prostate cancer: a PCCTC trial. Cancer Chemother Pharmacol. 2012 Mar;69(3):763-71. doi: 10.1007/s00280-011-1759-9. Epub 2011 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'The present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.', 'detailedDescription': 'Cohorts of 1-6 patients will be administered AGS-1C404 in sequentially rising dose levels. Dose escalation will continue until the MTD of AGS-1C4D4 is established or the maximum planned dose is reached.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has hormone-refractory metastatic prostate cancer\n\nExclusion Criteria:\n\n* Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects\n* Patient is currently participating or has participated in an investigational study within the past 30 days\n* Patient has illness or circumstance that could limit compliance with the study requirements\n* Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year\n* Patient has Hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT00519233', 'briefTitle': 'AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': '2007001'}, 'secondaryIdInfos': [{'id': 'MK4721-003'}, {'id': '2007_535'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.AGS-1C4D4', 'interventionNames': ['Drug: AGS-1C4D4']}], 'interventions': [{'name': 'AGS-1C4D4', 'type': 'DRUG', 'description': 'IV', 'armGroupLabels': ['1.AGS-1C4D4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Agensys, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Agensys, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}