Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-03-21 @ 6:26 PM
Study NCT ID:
NCT00207103
Status:
COMPLETED
Last Update Posted:
2008-11-04
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C509922', 'term': 'brivanib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-03', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', '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 maximum 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 metastatic or solid tumors'], 'conditions': ['Tumors', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors\n* No tumor spread to the brain\n* Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)\n* Available tumor tissue sample from prior surgery\n* 4-6 weeks since prior therapy and recovered from prior therapy\n* Men and women, ages 18 and above\n* Women must not be pregnant or breastfeeding\n* Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer\n* Measurable disease on scans (at least one)'}, 'identificationModule': {'nctId': 'NCT00207103', 'briefTitle': 'MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA182-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Brivanib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Brivanib']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Brivanib']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Brivanib']}, {'type': 'EXPERIMENTAL', 'label': '5', 'interventionNames': ['Drug: Brivanib']}, {'type': 'EXPERIMENTAL', 'label': '6', 'interventionNames': ['Drug: Brivanab']}], 'interventions': [{'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 180 mg, once daily, until disease progression', 'armGroupLabels': ['1']}, {'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 320 mg, once daily, until disease progression', 'armGroupLabels': ['2']}, {'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 600 mg, once daily, until disease progression', 'armGroupLabels': ['3']}, {'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 800 mg, once daily, until disease progression', 'armGroupLabels': ['4']}, {'name': 'Brivanib', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression', 'armGroupLabels': ['5']}, {'name': 'Brivanab', 'type': 'DRUG', 'otherNames': ['BMS-582664'], 'description': 'Tablets, Oral, 1000 mg, once daily, until disease progression', 'armGroupLabels': ['6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Med Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University Of Wisconsin Comprehensive Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': 'HA6 2RN', 'city': 'Middlesex', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], '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'}}}}