Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT03899792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2019-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
Sponsor:
Organization:
Raw JSON
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'term': 'Thyroid Diseases'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656166', 'term': 'selpercatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03906331', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Advanced Solid Tumors: Dose Limiting Toxicities (DLTs)', 'timeFrame': 'During the first 28-day cycle of LOXO-292 treatment', 'description': 'For Phase 1'}, {'measure': 'To Determine the Safety of Oral LOXO-292 in Pediatric Participants with Primary CNS Tumors: DLTs', 'timeFrame': 'During the first 28-day cycle of LOXO-292 treatment', 'description': 'For Phase 1'}, {'measure': 'Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Independent Review Committee (IRC)', 'timeFrame': 'Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months)', 'description': 'For Phase 2'}, {'measure': 'ORR Based on Response Assessment in Neuro-Oncology (RANO) per IRC', 'timeFrame': 'Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months)', 'description': 'For Phase 2'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentrations of LOXO-292', 'timeFrame': 'Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)', 'description': 'Phase 1'}, {'measure': 'Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of LOXO-292', 'timeFrame': 'Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)', 'description': 'Phase 1 and Phase 2'}, {'measure': 'Maximum Concentration (Cmax) of LOXO-292', 'timeFrame': 'Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)', 'description': 'Phase 1 and Phase 2'}, {'measure': 'Time to Maximum Concentration (Tmax) of LOXO-292', 'timeFrame': 'Days 1 and 8 of Cycle 1, Day 1 of Cycle 3 and Day 8 after Intra-participant Dose Escalation (each cycle is 28 days)', 'description': 'Phase 1 and Phase 2'}, {'measure': 'Recommended LOXO-292 Dose for Phase 2 (MTD)', 'timeFrame': 'Cycle 1 (28 days)', 'description': 'For Phase 1'}, {'measure': 'To Assess the Preliminary Anti-Tumor Activity of LOXO-292 in Pediatric Participants with Tumors Harboring an Activating RET Alteration as Determined by ORR Based on RECIST v1.1', 'timeFrame': 'Baseline to Progressive Disease or Death due to any cause (Estimated up to 12 months)', 'description': 'For Phase 1'}, {'measure': "Changes from Baseline in Pain Measures as Measured by Wong Baker Faces scales. Wong-Baker Faces Pain Scale includes pictures of facial expressions with correlating scores of 0 being 'no hurt' and 10 being 'hurts worst'.", 'timeFrame': 'Up to 24 months', 'description': 'For Phase 1'}, {'measure': "Changes from Baseline in Health Related Quality of Life Measures as Measured by Pediatric Quality of Life (PedsQoL) Inventory Core. PedsQoL includes a list of problems with scores of 0 being 'never a problem' and 4 being 'almost always a problem'.", 'timeFrame': 'Up to 24 months', 'description': 'For Phase 1'}, {'measure': 'Objective Response Rate as Assessed by RECIST v1.1, as Assessed by Investigator', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Objective Response Rate as Assessed by RANO, as Assessed by Investigator', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Duration of Response (DOR) as Assessed by Investigator', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Duration of Response (DOR) as Assessed by the IRC', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Progression Free Survival (PFS) as Assessed by Investigator', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'PFS as Assessed by IRC', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, and 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Clinical Benefit Rate (by Investigator)', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Clinical Benefit Rate (by IRC)', 'timeFrame': 'Approximately every 8 weeks for one year, then every 12 weeks, 7 days after the last dose (for up to 2 years) in participants who have not progressed.', 'description': 'For Phase 2'}, {'measure': 'Frequency of Adverse Events (AEs)', 'timeFrame': 'From the time of informed consent, for approximately 24 months (or earlier if the participants discontinues from the study), and through Safety Follow-up (28 days after the last dose)', 'description': 'For Phase 2'}, {'measure': "To Evaluate the Concordance of Prior Molecular that Detected a RET Alteration within the Participant's Tumor with Diagnostic Tests Being Evaluated by Sponsor", 'timeFrame': '6 months', 'description': 'For Phase 2'}, {'measure': 'Phase 2: Post-Operative Stage on Participants Treated with LOXO-292', 'timeFrame': 'Up to 3 years', 'description': 'Tumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC)'}, {'measure': 'Phase 2: Surgical Margin Status in Participants Treated with LOXO-292', 'timeFrame': 'Up to 3 years', 'description': 'Tumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor.'}, {'measure': 'Descriptive Analysis of Pretreatment Surgical Plan', 'timeFrame': 'Up to 3 years', 'description': 'For Phase 2'}, {'measure': 'Descriptive Analysis of Post-Treatment Plans', 'timeFrame': 'Up to 3 years', 'description': 'For Phase 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loxo', 'LOXO-292', 'KIF5B-RET', 'M918T', 'CCDC6-RET', 'RET-PTC1', 'NCOA4-RET', 'RET-PTC', 'RET-PTC3', 'RET-PTC4', 'PRKAR1A-RET', 'RET-PTC2', 'GOLGA5-RET', 'RET-PTC5', 'ERC1-RET', 'KTN1-RET', 'RET-PTC8', 'HOOK3-RET', 'PCM1-RET', 'TRIM24-RET', 'RET-PTC6', 'TRIM27-RET', 'TRIM33-RET', 'RET-PTC7', 'AKAP13-RET', 'FKBP15-RET', 'SPECC1L-RET', 'TBL1XR1-RET', 'BCR-RET', 'FGRF1OP-RET', 'RFG8-RET', 'RET-PTC9', 'ACBD5-RET', 'MYH13-RET', 'CUX1-RET', 'KIAA1468-RET', 'FRMD4A-RET', 'SQSTM1-RET', 'AFAP1L2-RET', 'PPFIBP2-RET', 'EML4-RET', 'PARD3-RET', 'G533C', 'C609F', 'C609G', 'C609R', 'C609S', 'C609Y', 'C611F', 'C611G', 'C611S', 'C611Y', 'C611W', 'C618F', 'C618R', 'C618S', 'C620F', 'C620R', 'C620S', 'C630R', 'C630Y', 'D631Y', 'C634F', 'C634G', 'C634R', 'C634S', 'C634W', 'C634Y', 'K666E', 'E768D', 'L790F', 'V804L', 'V804M', 'A883F', 'S891A', 'R912P', 'CLIP1-RET', 'Y806C', 'RET fusion', 'RET alteration', 'RET mutation', 'RET rearrangement', 'RET translocation', 'Neoplasms by Site', 'Neoplasms', 'Non-Small Cell Lung Cancer', 'Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung', 'Cancer of Lung', 'Cancer of the Lung', 'Lung Cancer', 'Neoplasms, Lung', 'Neoplasms, Pulmonary', 'Pulmonary Cancer', 'Pulmonary Neoplasms', 'Respiratory Tract Neoplasms', 'Lung Diseases', 'Respiratory Tract Diseases', 'Carcinoma, Bronchogenic', 'Bronchial Neoplasms', 'Medullary Thyroid Cancer', 'Papillary Thyroid Cancer', 'Thyroid Diseases', 'Thyroid Neoplasms', 'Cancer of the Thyroid', 'Cancer of Thyroid', 'Neoplasms, Thyroid', 'Thyroid Adenoma', 'Thyroid Cancer', 'Thyroid Carcinoma', 'Endocrine System Diseases', 'Endocrine Gland Neoplasms', 'Head and Neck Neoplasms', 'Thoracic Neoplasms', 'CNS tumor', 'Primary CNS tumor', 'Colonic Neoplasms', 'Cancer of Colon', 'Cancer of the Colon', 'Colon Cancer', 'Colon Neoplasms', 'Colonic Cancer', 'Neoplasms, Colonic', 'Malignant tumor of Breast', 'Mammary Cancer', 'Mammary Carcinoma, Human', 'Mammary Neoplasm, Human', 'Neoplasms, Breast', 'Tumors, Breast', 'Human Mammary Carcinoma', 'Malignant Neoplasm of Breast', 'Breast Carcinoma', 'Breast Tumors', 'Cancer of the Breast', 'Breast Neoplasms', 'Breast Cancer', 'RET Inhibitor', 'MTC', 'NSCLC', 'Soft tissue sarcoma', 'Infantile Myofibromatosis', 'Infantile Fibrosarcoma'], 'conditions': ['Medullary Thyroid Cancer', 'Infantile Myofibromatosis', 'Infantile Fibrosarcoma', 'Papillary Thyroid Cancer', 'Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.', 'detailedDescription': 'This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies\n* Evidence of an activating RET gene alteration in the tumor and/or blood\n* Measurable or non-measurable disease\n* Karnofsky (participants 16 years and older) or Lansky (participants younger than 16) performance score of at least 50\n* Participant with primary CNS tumors or cerebral metastases must be neurologically stable for 7 days prior and must not have required increasing doses of steroids within the last 7 days\n* Adequate hematologic, hepatic and renal function.\n* Ability to receive study drug therapy orally or via gastric access\n* Willingness of men and women of reproductive potential to observe conventional and effective birth control\n\nExclusion Criteria:\n\n* Major surgery within two weeks prior to planned start of LOXO-292\n* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292\n* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection\n* Clinically significant active malabsorption syndrome\n* Pregnancy or lactation\n* Uncontrolled symptomatic hyperthyroidism or hypothyroidism (i.e. the participant required a modification to current thyroid medication in the 7 days before start of LOXO-292)\n* Uncontrolled symptomatic hypercalcemia or hypocalcemia\n* Known hypersensitivity to any of the components of the investigational agent, LOXO-292 or Ora-Sweet® SF and OraPlus®, for participants who will receive LOXO-292 suspension\n* Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor\\[s\\])'}, 'identificationModule': {'nctId': 'NCT03899792', 'acronym': 'LIBRETTO-121', 'briefTitle': 'A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors', 'orgStudyIdInfo': {'id': '17493'}, 'secondaryIdInfos': [{'id': 'J2G-OX-JZJJ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'LOXO-RET-18036', 'type': 'OTHER', 'domain': 'LOXO Oncology, Inc.'}, {'id': '2019-000212-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LOXO-292', 'description': 'Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1', 'interventionNames': ['Drug: LOXO-292']}], 'interventions': [{'name': 'LOXO-292', 'type': 'DRUG', 'otherNames': ['Selpercatinib', 'LY3527723'], 'description': 'Oral LOXO-292', 'armGroupLabels': ['LOXO-292']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital for Cancer and Blood Disorders", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Health", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390-9063', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital Research Foundation", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '69115', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}, {'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '8035', 'city': 'Barcelona', 'state': 'Barcelona [Barcelona]', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'NW1 2BU', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'University College Hospital - London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loxo Oncology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}