Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-02-20 @ 1:33 AM
Study NCT ID:
NCT00860158
Status:
TERMINATED
Last Update Posted:
2018-03-14
First Post:
2009-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], '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'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsmith@hoosiercancer.org', 'phone': '317-921-2050', 'title': 'Principal Investigator', 'organization': 'Hoosier Cancer Research Network, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was terminated due to slow accrual and no results were analyzed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAEv3'}, {'term': 'FATIGUE (ASTHENIA, LETHARGY, MALAISE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAEv3'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAEv3'}, {'term': 'TASTE ALTERATION (DYSGEUSIA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAEv3'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Estimate the Pathologic Complete Response (pCR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were analyzed for pCR due to study termination'}, {'type': 'SECONDARY', 'title': 'To Estimate Partial Pathologic Responses (pPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Estimate PSA Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for this secondary objective was not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'To Estimate Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Estimate Safety and Tolerability of LHRH Plus Dasatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'timeFrame': '18 months', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Arm', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Arm', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy\n\nDasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days\n\nLeuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nRadical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', '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': 1}}, 'statusModule': {'whyStopped': 'Slow accrual; closed by funder', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-14', 'studyFirstSubmitDate': '2009-03-11', 'resultsFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-07', 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Estimate the Pathologic Complete Response (pCR) Rate', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'To Estimate Partial Pathologic Responses (pPR)', 'timeFrame': '18 months'}, {'measure': 'To Estimate PSA Response Rate', 'timeFrame': '18 months'}, {'measure': 'To Estimate Progression Free Survival', 'timeFrame': '18 months'}, {'measure': 'To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers', 'timeFrame': '18 months'}, {'measure': 'To Estimate Safety and Tolerability of LHRH Plus Dasatinib', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hoosieroncologygroup.org', 'label': 'Hoosier Oncology Group Homepage'}]}, 'descriptionModule': {'briefSummary': 'This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.', 'detailedDescription': 'OUTLINE: This is a multi-center study.\n\n* Dasatinib -100 mg administered once daily per oral route for 28 consecutive days.\n* Leuprolide acetate - 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).\n\nThe 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.\n\nRadical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.\n\nEastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n\nHematopoietic:\n\n* Hemoglobin (Hgb) ≥ 8.0 g/dL\n* Platelets ≥ 100 K/mm3\n* Absolute neutrophil count (ANC) ≥ 1.0 K/mm3\n\nHepatic:\n\n* Total bilirubin \\< 2.0 X Upper Limit Normal (ULN)\n* Aspartate aminotransferase (AST) \\< 2.5 X ULN\n* Alanine aminotransferase (ALT) \\< 2.5 X ULN\n\nRenal:\n\n* Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula\n\nCardiovascular:\n\n* No uncontrolled angina, congestive heart failure or myocardial infarction within 6 months prior to registration for protocol therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Clinical stage T1-T3a disease.\n* Must be willing to have a tumor biopsy, if previous tumor tissue unavailable for tumor marker analysis.\n* Kattan pre-operative nomogram-predicted (based on stage, Prostate Specific Antigen (PSA) and Gleason score) 5-year risk of recurrence-free survival of 80% or less\n* Must be deemed eligible for radical prostatectomy.\n* Must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.\n* Written informed consent and HIPAA authorization for release of personal health information.\n* Age \\> 18 years at the time of consent.\n\nExclusion Criteria:\n\n* No evidence of regional, lymph node or distant metastasis on clinical or radiological assessments. All baseline radiology studies must be performed within 28 days prior to registration for protocol therapy.\n* No prior malignancy in the past 2 years except for basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), and colonic polyp with focus of adenocarcinoma) can be enrolled after approval from the Sponsor Investigator.\n* No prior hormonal therapy with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Patients who have received prior oral anti-androgen therapies (bicalutamide, flutamide, nilutamide, etc.), prior LHRH agonist therapy (leuprolide, goserelin acetate, etc.), or prior orchiectomy are ineligible.\n* No prior systemic chemotherapy or radiotherapy for prostate cancer is allowed. Transurethral resection of the prostate for benign prostatic hypertrophy (BPH) and oral alpha-blockers (terazosin, tamsulosin, doxazosin) are permitted.\n* No history of hemorrhage or thrombotic events (cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) within 6 months prior to registration for protocol therapy.\n* No history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n* No history of diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) of registration on protocol therapy.\n* No history of ongoing or recent (≤ 3 months of registration on protocol therapy) significant gastrointestinal bleeding\n* No ongoing anti-coagulation and/or anti-platelet therapies allowed.\n* No unresolved pleural or pericardial effusion of any grade within 3 months of registration for protocol therapy.\n* No uncontrolled angina, congestive heart failure or MI within 6 months prior to registration for protocol therapy.\n* No diagnosed congenital long QT syndrome.\n* No history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).\n* No prolonged QTc interval on pre-entry electrocardiogram (\\> 450 msec)\n* Following medications must be discontinued at least 7 days prior to registration for protocol therapy and be withheld for the duration of dasatinib therapy:\n* Drugs that are generally accepted to have a risk of causing Torsades de Pointes\n* Patient must not be receiving any prohibited CYP3A4 inhibitors /inducers/ substrates\n* Anti-coagulation and/or anti-platelet therapies - to avoid potential bleeding risks.\n* No major surgical procedure, open biopsy, or significant trauma within 28 days prior to registration for protocol therapy.\n* Ability to comply with study and/or follow-up procedures and requirements.\n* No treatment with any investigational agent for any medical condition within 28 days prior to registration for protocol therapy.\n* No clinically significant infections or any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive the study drug.\n* Ability to take oral medication (dasatinib must be swallowed whole).\n* No known history of hypokalemia that cannot be corrected prior to registration on protocol therapy.\n* No known history of hypomagnesemia that cannot be corrected prior to registration on protocol therapy."}, 'identificationModule': {'nctId': 'NCT00860158', 'briefTitle': 'Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hoosier Cancer Research Network'}, 'officialTitle': 'A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'HOG GU07-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm Assignment', 'description': 'Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy', 'interventionNames': ['Drug: Dasatinib', 'Drug: Leuprolide Acetate (LHRH Analogue)', 'Procedure: Radical Prostatectomy']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Dasatinib 100 mg administered once daily per oral route for 28 consecutive days', 'armGroupLabels': ['Single Arm Assignment']}, {'name': 'Leuprolide Acetate (LHRH Analogue)', 'type': 'DRUG', 'description': 'Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).', 'armGroupLabels': ['Single Arm Assignment']}, {'name': 'Radical Prostatectomy', 'type': 'PROCEDURE', 'description': 'Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.', 'armGroupLabels': ['Single Arm Assignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Medical & Surgical Specialists, LLC', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Noah Hahn, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoosier Cancer Research Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noah Hahn, M.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Noah Hahn, M.D.', 'investigatorAffiliation': 'Hoosier Cancer Research Network'}}}}