Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT01491633
Status:
TERMINATED
Last Update Posted:
2014-07-15
First Post:
2011-10-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dasatinib in Advanced Squamous Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phammerman@partners.org', 'phone': '617-632-3000', 'title': 'Dr. Peter Hammerman', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the toxicity of the study agent no subjects were evaluable for response'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Elevated LFTs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No subjects were evaluable for response', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Types and Frequency of DDR2 Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Determine frequency of DDR2 mutations in study patients', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'spread': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Establish the overall survival of patients with SCC treated with dasatinib', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject who was alive at the end of the study was censored from the survival analysis'}, {'type': 'SECONDARY', 'title': 'Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.', 'unitOfMeasure': 'grade 3 toxicities', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Time on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Number of days participant remained on study', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day\n\nDasatinib: 140 mg orally, daily in 28 day cycles'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', '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': 5}}, 'statusModule': {'whyStopped': 'Safety issues/concerns per DF/HCC PI', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-14', 'studyFirstSubmitDate': '2011-10-05', 'resultsFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2011-12-12', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-14', 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': '2 years', 'description': 'Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib'}], 'secondaryOutcomes': [{'measure': 'Types and Frequency of DDR2 Mutations', 'timeFrame': '2 years', 'description': 'Determine frequency of DDR2 mutations in study patients'}, {'measure': 'Survival', 'timeFrame': '2 years', 'description': 'Establish the overall survival of patients with SCC treated with dasatinib'}, {'measure': 'Toxicities', 'timeFrame': '2 years', 'description': 'Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung cancer', 'NSCLC', 'Stage IIIB', 'Stage IV'], 'conditions': ['Squamous Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '24128713', 'type': 'RESULT', 'citation': 'Brunner AM, Costa DB, Heist RS, Garcia E, Lindeman NI, Sholl LM, Oxnard GR, Johnson BE, Hammerman PS. Treatment-related toxicities in a phase II trial of dasatinib in patients with squamous cell carcinoma of the lung. J Thorac Oncol. 2013 Nov;8(11):1434-7. doi: 10.1097/JTO.0b013e3182a47162.'}]}, 'descriptionModule': {'briefSummary': 'Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.\n\nAdvanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.\n\nAn open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.', 'detailedDescription': 'Dasatinib will be taken orally, daily in cycles of 28 days.\n\nOn the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:\n\n* Medical history and clinical exam\n* Safety blood tests\n* Measurement of Performance Status\n* Review of pill log\n* CT scans will be done every 8 weeks.\n\nIn this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.\n\nDasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage III/B or IV squamous NSCLC\n* Measurable disease\n* Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer\n* ECOG performance status of 0 or 1\n* Estimated life expectancy greater than 12 weeks\n* Normal organ and marrow function\n* Confirmed availability of archival pathology samples\n* Agrees to discontinue St. Johns Wort\n* Able to take medications by mouth\n* Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding\n* Chemotherapy or radiotherapy within 4 weeks prior to entering study\n* Receiving any other investigational agents\n* Known untreated or progressive brain metastases\n* History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib\n* Taking medications known to be potent CYP3A4 inhibitors\n* Currently taking H2 inhibitors or proton pump inhibitors\n* Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes\n* HIV positive\n* Clinically uncontrolled hypertension (blood pressure \\> 160/110)\n* Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years\n* Active and uncontrolled clinically significant infection\n* Chronic gastrointestinal disease\n* Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months\n* Supplemental oxygen required for current malignancy\n* Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care\n* Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration'}, 'identificationModule': {'nctId': 'NCT01491633', 'briefTitle': 'Dasatinib in Advanced Squamous Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer', 'orgStudyIdInfo': {'id': '11-142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dasatinib', 'description': 'Dasatinib 140 mg by mouth each day', 'interventionNames': ['Drug: Dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['BMS-354825'], 'description': '140 mg orally, daily in 28 day cycles', 'armGroupLabels': ['Dasatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Bruce Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Bruce Johnson, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}