Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-03-26 @ 9:33 AM
Study NCT ID:
NCT00971867
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
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Approximately up to 28 months', 'description': 'Number of Participants with SAEs', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel', 'description': 'Each vial (16.7 mL) contains 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first infusion to the completion of study. 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Approximately up to 42 Months', 'description': 'Best overall response is represented by the number participants who have had complete response, partial response and not completed.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response as Per RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel', 'description': 'Each vial (16.7 mL) contains 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '847'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel', 'description': 'Each vial (16.7 mL) contains 100 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '140', 'upperLimit': '904'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'Best overall response is represented by the number participants who have had complete response, partial response and not completed.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paclitaxel', 'description': 'Each vial (16.7 mL) contains 100 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Participant Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '11 Participants Treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paclitaxel', 'description': 'Each vial (16.7 mL) contains 100 mg'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2009-09-03', 'resultsFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-16', 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With SAEs', 'timeFrame': 'From the first infusion to the completion of study. Approximately up to 28 months', 'description': 'Number of Participants with SAEs'}, {'measure': 'Number of Participants With Adverse Events Leading to Discontinuation', 'timeFrame': 'From the first infusion to the completion of study. Approximately up to 28 months', 'description': 'Number of Participants with Adverse Events Leading to Discontinuation'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From the first infusion to the completion of study. Approximately up to 28 months', 'description': 'Number of Participants with Adverse Events'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'From the first infusion to the completion of study. Approximately up to 28 months', 'description': 'Number of Participants with Laboratory Abnormalities'}, {'measure': 'Number of Participants With Drug Related Laboratory Abnormalities', 'timeFrame': 'From the first infusion to the completion of study. Approximately up to 28 months', 'description': 'Number of Participants with Drug Related Laboratory Abnormalities'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Best Overall Response Per RECIST Criteria', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.'}, {'measure': 'Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'Best overall response is represented by the number participants who have had complete response, partial response and not completed.'}, {'measure': 'Duration of Overall Response as Per RECIST Criteria', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867).'}, {'measure': 'Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer', 'timeFrame': 'From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months', 'description': 'Best overall response is represented by the number participants who have had complete response, partial response and not completed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator'}, 'identificationModule': {'nctId': 'NCT00971867', 'briefTitle': 'Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'CA139-539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel', 'interventionNames': ['Drug: Paclitaxel']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxol', 'BMS-181339'], 'description': 'Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent', 'armGroupLabels': ['Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2778577', 'city': 'Kashiwa-shi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '8900075', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '241-0815', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '5458586', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '4118777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Local Institution'}, {'zip': '1520021', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '329-0498', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}