Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00329004
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2006-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552150', 'term': 'BMS-690514'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2006-05-19', 'studyFirstSubmitQcDate': '2006-05-19', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks'}, {'measure': 'Highest dose tolerated', 'timeFrame': 'continuous medical review of adverse event reports'}], 'secondaryOutcomes': [{'measure': 'Effective dose or doses of BMS-690514', 'timeFrame': 'tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports'}]}, 'conditionsModule': {'keywords': ['Solid Tumors'], 'conditions': ['Cancer', 'Tumor']}, 'referencesModule': {'references': [{'pmid': '23490650', 'type': 'DERIVED', 'citation': 'Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 and older\n* Diagnosis of any solid tumor\n* ECOG performance status score 0-1\n* Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment\n* Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)\n\nExclusion Criteria:\n\n* Treatment with other TKIs within the past 4 weeks\n* Patients with brain metastasis\n* Patients with centrally located squamous cell carcinoma of the lung\n* Major gastrointestinal surgery which may affect absorption of the drug\n* Any surgery within last 4 weeks\n* History of thromboembolism\n* Severe unmanageable diarrhea\n* Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)\n* Part B/Cohort I erlotinib-naive subjects\n* Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)'}, 'identificationModule': {'nctId': 'NCT00329004', 'briefTitle': 'A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA187-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: BMS-690514']}], 'interventions': [{'name': 'BMS-690514', 'type': 'DRUG', 'otherNames': ['panHER'], 'description': 'Tablets, Oral, up to 300 mg, once daily, up to 24 mos', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Med Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University Of Texas Md Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], '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'}}}}