Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00605618
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2008-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C550356', 'term': 'N-(4-(2-amino-3-chloropyridin-4-yloxy)-3-fluorophenyl)-4-ethoxy-1-(4-fluorophenyl)-2-oxo-1,2-dihydropyridine-3-carboxamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2008-01-18', 'studyFirstSubmitQcDate': '2008-01-18', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy assessment including vitals signs, physical assessments, and blood tests', 'timeFrame': 'will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months'}, {'measure': 'Tumor assessments', 'timeFrame': 'will be conducted every 6 weeks. All assessments will continue for at least 24 months'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669', 'timeFrame': 'will be assessed once weekly for the first 3 weeks'}, {'measure': 'The effects of BMS-777607 on blood pressure (BP), heart rate (HR)', 'timeFrame': 'will be assessed once weekly for the first 3 weeks then every 3 weeks'}, {'measure': 'Effects on electrocardiogram (ECG), PR interval', 'timeFrame': 'will be assessed at base line, at week 3 and at end of treatment'}, {'measure': 'Effects on left ventricular function', 'timeFrame': 'will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors\n\nPart B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A:\n\n* Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known\n\nPart B:\n\n* Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on standard therapy, or for whom standard therapy is not known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will be treated. Subjects with PRCC (up to 18) will be enrolled as feasible\n* Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must be provided\n* Subjects with HRPrC must have either measurable disease or rising PSA levels (≥3 consecutive rising levels with at least 1 week interval and with PSA level ≥5 mg/ml). All other subjects must have measurable disease as assessed by CT or MRI\n\nExclusion Criteria:\n\n* Know brain metastases\n* Uncontrolled or significant cardiovascular disease\n* Retinal atrophy'}, 'identificationModule': {'nctId': 'NCT00605618', 'briefTitle': 'Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'CA192-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: BMS-777607']}], 'interventions': [{'name': 'BMS-777607', 'type': 'DRUG', 'description': 'Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}], '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'}}}}