Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 3:50 PM
Study NCT ID:
NCT00359450
Status:
TERMINATED
Last Update Posted:
2010-03-02
First Post:
2006-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437188', 'term': 'BMS-275183'}, {'id': 'C080625', 'term': 'taxane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 186}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-07'}, 'statusVerifiedDate': '2007-09', 'dispFirstSubmitDate': '2010-02-27', 'lastUpdateSubmitDate': '2010-02-27', 'studyFirstSubmitDate': '2006-08-01', 'dispFirstSubmitQcDate': '2010-02-27', 'studyFirstSubmitQcDate': '2006-08-01', 'dispFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate'}], 'secondaryOutcomes': [{'measure': 'To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population'}, {'measure': 'Assess the response duration'}, {'measure': 'Assess the progression free survival time'}, {'measure': 'Assess the overall survival time'}, {'measure': 'Assess the pharmacokinetics (PK) of BMS-275183'}]}, 'conditionsModule': {'keywords': ['Locally advanced or metastatic non-small cell lung cancer'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:\n\n* Cohort I: Patients previously treated with one taxane containing regimen.\n* Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.\n* Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.\n\nPatients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age \\>= 18 years\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.\n\nExclusion Criteria:\n\n* Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer'}, 'identificationModule': {'nctId': 'NCT00359450', 'briefTitle': 'Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients', 'orgStudyIdInfo': {'id': 'CA165-026'}, 'secondaryIdInfos': [{'id': 'EUDRACT: 2005-005099-33'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'BMS-275183 (oral taxane)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Morganton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.74541, 'lon': -81.68482}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Montreal', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution'}, {'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'city': 'Belfort', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'city': 'Besançon', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Tours', 'country': 'France', 'facility': 'Local Institution', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Orbassano Torino', 'country': 'Italy', 'facility': 'Local Institution'}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Glasgow', 'state': 'Central', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Northwood', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Local Institution', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}}}}