Viewing Study NCT00590902


Ignite Creation Date: 2025-12-25 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
Study NCT ID: NCT00590902
Status: COMPLETED
Last Update Posted: 2023-10-16
First Post: 2007-12-26
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer
Sponsor:
Organization:

Raw JSON

{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krism@mskcc.org', 'phone': '646-888-4205', 'title': 'Dr. Mark Kris', 'organization': 'Memorial Sloan Kettering Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 - OSI-774', 'description': 'OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets', 'otherNumAtRisk': 81, 'otherNumAffected': 66, 'seriousNumAtRisk': 81, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Dermatology, skin other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hemoglobin (Hgb)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Prothrombin time (PT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Rash, desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 44, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'SGPT (ALT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}], 'seriousEvents': [{'term': 'Abdominal pain/cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Adult Respiratory Distress Syndrome (ARDS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Infection without neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Mood alteration - Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Mood alteration - Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Neurology, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Pulmonary, other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Vision-double vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTC-2.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Objective Response of OSI-774', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '1 - OSI-774', 'description': 'OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease (SD)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Progression of Disease (POD)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '53 weeks', 'description': '(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 - OSI-774', 'description': 'OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '1 - OSI-774', 'description': 'OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', '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': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-15', 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Objective Response of OSI-774', 'timeFrame': '53 weeks', 'description': '(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non small cell lung cancer'], 'conditions': ['Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer.\n\nThis study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either bronchioloalveolar cell carcinoma or a variant thereof after review\n* Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease\n* Measurable or evaluable indicator lesions\n* No prior or one chemotherapy regimen for NSCLC\n* Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area\n* Karnofsky performance status \\> or = to 80% OR ECOG performance status ≤ or = to 1\n* Life expectancy \\> or = to 8 weeks\n* Adequate hematologic, renal and/or hepatic function: WBC \\> or = to 3,000/ul, hemoglobin \\> or = to 9.0 g/dl, platelet count \\> or = to 100,000/ul, total bilirubin \\< or = to 1.0 mg/dl, AST \\< than or = to 2.5 X UNL, creatinine \\< or = to 1.5 mg/dl or Clcr \\> or = to 55ml/min.\n* Effective contraception\n\nExclusion Criteria:\n\n* Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.)\n* Two or more prior chemotherapy regimens\n* Concurrent active cancer\n* Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids)\n* Pregnant or lactating women\n* Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin\n* Prior systemic cytotoxic chemotherapy for other malignant disease\n* Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).'}, 'identificationModule': {'nctId': 'NCT00590902', 'briefTitle': 'Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer', 'orgStudyIdInfo': {'id': '02-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 - OSI-774', 'interventionNames': ['Drug: OSI-774: erlotinib, TarcevaTM']}], 'interventions': [{'name': 'OSI-774: erlotinib, TarcevaTM', 'type': 'DRUG', 'description': '150 mg, 100 mg and 25 mg tablets', 'armGroupLabels': ['1 - OSI-774']}]}, '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': 'Christopher Azzoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}