Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT00207051
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509922', 'term': 'brivanib'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessment', 'timeFrame': 'throughout the study'}, {'measure': 'dose limiting toxicity (DLT)', 'timeFrame': 'assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified'}, {'measure': 'determination of maximum tolerated dose (MTD)', 'timeFrame': 'during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximu tolerated dose is identified'}], 'secondaryOutcomes': [{'measure': 'Efficacy based on duration of response and time to progression based on assessment', 'timeFrame': 'Measured every 8 weeks throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Gastrointestinal Malignancies'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '21131369', 'type': 'DERIVED', 'citation': 'Jonker DJ, Rosen LS, Sawyer MB, de Braud F, Wilding G, Sweeney CJ, Jayson GC, McArthur GA, Rustin G, Goss G, Kantor J, Velasquez L, Syed S, Mokliatchouk O, Feltquate DM, Kollia G, Nuyten DSA, Galbraith S. A phase I study to determine the safety, pharmacokinetics and pharmacodynamics of a dual VEGFR and FGFR inhibitor, brivanib, in patients with advanced or metastatic solid tumors. Ann Oncol. 2011 Jun;22(6):1413-1419. doi: 10.1093/annonc/mdq599. Epub 2010 Dec 3.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy\n* Feeling well other than cancer diagnosis (ie lab work, no infection, etc)\n* Available tumor tissue sample from prior surgery\n* Measurable disease on scans\n* 4-6 weeks since prior therapy and recovered from the effects of prior therapy\n* Men and women, ages 18 and above\n* Women must not be pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00207051', 'briefTitle': 'BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Combination With Full Dose Erbitux in Patients With Advanced Gastrointestinal Malignancies Who Have Failed Prior Therapy', 'orgStudyIdInfo': {'id': 'CA182-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Brivanib + Cetuximab']}], 'interventions': [{'name': 'Brivanib + Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux', 'BMS-564717'], 'description': 'Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Usc/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetn Univ Lombardi Can Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33010', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami Miller School Of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': 'L8V 2C5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], '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'}}}}