Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT00792558
Status:
WITHDRAWN
Last Update Posted:
2015-09-01
First Post:
2008-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2008-11-17', 'studyFirstSubmitQcDate': '2008-11-17', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers', 'timeFrame': 'Within the first 21 days after first dose of BMS-817378'}], 'secondaryOutcomes': [{'measure': 'Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors', 'timeFrame': 'All time points while subject is on study'}, {'measure': 'Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)', 'timeFrame': 'Day 22 +/-2'}, {'measure': 'Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833', 'timeFrame': 'Days 1 and 15'}, {'measure': 'Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction', 'timeFrame': 'All time points while subject is on study'}, {'measure': 'Describe preliminary evidence for anti-tumor activity of BMS-817378', 'timeFrame': 'Every 6 weeks'}]}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer\n* ECOG status 0-1\n\nExclusion Criteria:\n\n* WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding\n* Symptomatic brain metastasis\n* Uncontrolled or significant cardiovascular disease\n* History of thromboembolic events or bleeding diathesis in past 6 months\n* Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy\n* Serious non-healing wounds, ulcers or bone fractures in past 3 months\n* Hemorrhage or bleeding event \\>= CTCAE grade 3 in past 4 weeks\n* Proteinuria \\>= 2+ on dipstick or \\>= 1gm/24 hours\n* Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product\n* Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers'}, 'identificationModule': {'nctId': 'NCT00792558', 'briefTitle': 'Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA195-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: BMS-817378']}], 'interventions': [{'name': 'BMS-817378', 'type': 'DRUG', 'description': 'Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Local Institution', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}