Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-09 @ 10:32 AM
Study NCT ID:
NCT00788333
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2008-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545990', 'term': 'BMS 754807'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], '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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-12', 'studyFirstSubmitDate': '2008-11-07', 'studyFirstSubmitQcDate': '2008-11-07', 'lastUpdatePostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis', 'timeFrame': 'Every 30 days until MTD is reached'}], 'secondaryOutcomes': [{'measure': 'Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)', 'timeFrame': 'Every 8 weeks'}, {'measure': 'Evaluate safety and tolerability of the combination regimen', 'timeFrame': 'Ongoing'}, {'measure': 'Assess effect of combination therapy on glucose metabolism', 'timeFrame': 'At 30 days, then every 8 weeks'}, {'measure': 'Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia', 'timeFrame': 'Ongoing'}, {'measure': 'Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis', 'timeFrame': 'Days, 1,8,15,22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced or Metastatic Her-2-positive Breast Cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'For additional information on this trial, please call (910) 558-2913\n\nInclusion Criteria:\n\n* Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed\n* Histologic or cytologic diagnosis of Her-2-positive breast cancer\n* ECOG status 0 - 1\n\nExclusion Criteria:\n\n* Symptomatic brain metastasis\n* Any condition requiring chronic use of steroids\n* Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms\n* History of glucose intolerance\n* Women of child-bearing potential unwilling or unable to use acceptable contraception methods'}, 'identificationModule': {'nctId': 'NCT00788333', 'briefTitle': 'Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer', 'orgStudyIdInfo': {'id': 'CA191-004'}, 'secondaryIdInfos': [{'id': 'EUDRACT #: 2009-013766-78'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Combination', 'interventionNames': ['Drug: BMS-754807', 'Drug: trastuzumab (Herceptin®)']}], 'interventions': [{'name': 'BMS-754807', 'type': 'DRUG', 'otherNames': ['IGF-IR'], 'description': 'Tablets, Oral, Dose escalation to MTD, then MTD to response/EOT, once daily, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop', 'armGroupLabels': ['A']}, {'name': 'trastuzumab (Herceptin®)', 'type': 'DRUG', 'otherNames': ['Herceptin®'], 'description': 'IV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5037', 'city': 'Kurralta Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -34.95142, 'lon': 138.56702}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3526', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}