Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-27 @ 8:26 AM
Study NCT ID:
NCT00513435
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D014062', 'term': 'Tongue Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515233', 'term': 'saracatinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'furym@mskcc.org', 'phone': '646-888-4233', 'title': 'Matthew Fury, MD', 'organization': 'Memorial Sloan-Kettering Cancer Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 14, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'AST, SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Death not assoc w CTCAE term- Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Inf norm ANC/gr1/2 neut-Cellulitis(skin)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Progression of Disease', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the start of treatment for up to 12 weeks', 'description': 'Response was determined as inicated in the protocol.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '1605'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 weeks', 'description': 'The Kaplan-Meier method will be used to estimate overall survival.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Protocol Open to Accrual 08/22/2006 Protocol Closed to Accrual 07/14/2009 Primary Completion Date 03/08/2011 Recruitment Location is the medical clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.'}], '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': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '13.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2007-08-06', 'resultsFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-13', 'studyFirstPostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'From the start of treatment for up to 12 weeks', 'description': 'Response was determined as inicated in the protocol.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 12 weeks', 'description': 'The Kaplan-Meier method will be used to estimate overall survival.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma', 'Recurrent Metastatic Squamous Neck Cancer With Occult Primary', 'Recurrent Squamous Cell Carcinoma of the Hypopharynx', 'Recurrent Squamous Cell Carcinoma of the Larynx', 'Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Recurrent Squamous Cell Carcinoma of the Nasopharynx', 'Recurrent Squamous Cell Carcinoma of the Oropharynx', 'Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity', 'Recurrent Verrucous Carcinoma of the Larynx', 'Recurrent Verrucous Carcinoma of the Oral Cavity', 'Stage III Squamous Cell Carcinoma of the Hypopharynx', 'Stage III Squamous Cell Carcinoma of the Larynx', 'Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage III Squamous Cell Carcinoma of the Nasopharynx', 'Stage III Squamous Cell Carcinoma of the Oropharynx', 'Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity', 'Stage III Verrucous Carcinoma of the Larynx', 'Stage III Verrucous Carcinoma of the Oral Cavity', 'Stage IV Squamous Cell Carcinoma of the Hypopharynx', 'Stage IV Squamous Cell Carcinoma of the Nasopharynx', 'Stage IVA Squamous Cell Carcinoma of the Larynx', 'Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage IVA Squamous Cell Carcinoma of the Oropharynx', 'Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity', 'Stage IVA Verrucous Carcinoma of the Larynx', 'Stage IVA Verrucous Carcinoma of the Oral Cavity', 'Stage IVB Squamous Cell Carcinoma of the Larynx', 'Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage IVB Squamous Cell Carcinoma of the Oropharynx', 'Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity', 'Stage IVB Verrucous Carcinoma of the Larynx', 'Stage IVB Verrucous Carcinoma of the Oral Cavity', 'Stage IVC Squamous Cell Carcinoma of the Larynx', 'Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity', 'Stage IVC Squamous Cell Carcinoma of the Oropharynx', 'Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity', 'Stage IVC Verrucous Carcinoma of the Larynx', 'Stage IVC Verrucous Carcinoma of the Oral Cavity', 'Tongue Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying the how well saracatinib works in treating patients with metastatic or recurrent head and neck cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the median progression-free survival for patients with advanced or recurrent squamous cell carcinoma of the head and neck (HNSCC) treated with AZD0530 (saracatinib).\n\nSECONDARY OBJEC TIVES:\n\nI. To determine overall survival for patients with advanced or recurrent HNSCC treated with AZD0530.\n\nII. To determine objective response rate for patients with advanced or recurrent HNSCC treated with AZD0530.\n\nIII. For patients with accessible tumors, to perform pre and post-treatment biopsies to assess the pharmacodynamic effects of AZD0530 on c-Src and downstream signaling molecules STAT3 and STAT5.\n\nOUTLINE:\n\nPatients receive saracatinib orally (PO) or by percutaneous endoscopic gastrostomy (PEG) tube once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up for 12 weeks and then periodically thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck\n\n * Persistent, recurrent, or metastatic disease that is not amenable to curative-intent therapy with surgery or radiation\n* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan\n* Karnofsky performance status ≥ 60%\n* White blood cell (WBC) ≥ 3,000/mcL\n* Absolute neutrophil count ≥ 1,500/mcL\n* Platelets ≥ 100,000/mcL\n* Hemoglobin \\> 9 g/dL\n* Total bilirubin within upper institutional limits of normal (ULN)\n* Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatinine within ULN OR creatinine clearance ≥ 60 mL/min\n* Patients must agree to use adequate birth control for the duration of study participation and for at least 8 weeks after discontinuation of study drug\n* May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic disease\n\nExclusion Criteria:\n\n* Known brain metastases\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530\n* Urine protein: creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg\n* QTc prolongation ≥ 480 msecs\n* Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia\n* History of myocardial infarction within the past year\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women\n* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy\n* Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or pneumonitis/pulmonary infiltrates ≥ grade 2\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study\n* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Use of specifically prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances\n\n * Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530\n* Patients receiving any other investigational agents'}, 'identificationModule': {'nctId': 'NCT00513435', 'briefTitle': 'Saracatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer', 'nctIdAliases': ['NCT01645618', 'NCT01664468'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of AZD0530 for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)', 'orgStudyIdInfo': {'id': 'NCI-2009-00192'}, 'secondaryIdInfos': [{'id': '06-074'}, {'id': 'CDR0000559632', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'N01CM62206', 'link': 'https://reporter.nih.gov/quickSearch/N01CM62206', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (enzyme inhibitor therapy)', 'description': 'Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: saracatinib', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'saracatinib', 'type': 'DRUG', 'otherNames': ['AZD0530'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (enzyme inhibitor therapy)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (enzyme inhibitor therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Matthew Fury', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}