Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-03-07 @ 11:46 PM
Study NCT ID:
NCT01709435
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2012-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558660', 'term': 'cabozantinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '16264470064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'description': 'Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 7, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accessory nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Avascular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Buttock pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac troponin I increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Movements involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reversible posterior leukoencephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tricuspid valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Cabozantinib S-malate)', 'description': 'Patients receive cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days', 'description': 'Maximum dose at which fewer than one-third of toxicity-evaluable patients experience a dose limiting toxicity during cycle 1 of therapy.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible Patients'}, {'type': 'PRIMARY', 'title': 'Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Number of toxicity-evaluable patients who experience a dose limiting toxicity during cycle 1 of therapy stratified by dose level and study part.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'toxicity-evaluable patients'}, {'type': 'PRIMARY', 'title': 'Clearance of Cabozantinib S-malate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1641.7', 'groupId': 'OG000', 'lowerLimit': '1020.4', 'upperLimit': '2222.2'}, {'value': '1724.1', 'groupId': 'OG001', 'lowerLimit': '1120.4', 'upperLimit': '4477.6'}, {'value': '3013.8', 'groupId': 'OG002', 'lowerLimit': '1556.4', 'upperLimit': '4366.8'}, {'value': '2281.4', 'groupId': 'OG003', 'lowerLimit': '2247.2', 'upperLimit': '2461.5'}, {'value': '2668.6', 'groupId': 'OG004', 'lowerLimit': '1252.6', 'upperLimit': '4801.9'}, {'value': '1363.8', 'groupId': 'OG005', 'lowerLimit': '1327.4', 'upperLimit': '1486.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 hours', 'description': 'Median (min, max) clearance of cabozantinib stratified by dose level and study part post-dose in cycle 1, day 1.', 'unitOfMeasure': 'ml/hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible Patients'}, {'type': 'SECONDARY', 'title': 'Disease Response of Cabozantinib S-malate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Number of response-evaluable patients with response (CR or PR) determined by RECIST guideline (version 1.1) including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in sum of diameters of target lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'response-evaluable patients'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) of Cabozantinib S-malate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '576', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '695'}, {'value': '1034', 'comment': 'The upper limit of the 95% CI is not estimable because the upper limit of the 95% confidence bands does not reach 0.50. This occurs in instances when not enough events have occurred to estimate the parameter.', 'groupId': 'OG001', 'lowerLimit': '1034', 'upperLimit': 'NA'}, {'value': '869', 'groupId': 'OG002', 'lowerLimit': '163', 'upperLimit': '1562'}, {'value': '256', 'groupId': 'OG003', 'lowerLimit': '190', 'upperLimit': '321'}, {'value': '737', 'groupId': 'OG004', 'lowerLimit': '115', 'upperLimit': '1617'}, {'value': '24', 'comment': 'The upper limit of the 95% CI is not estimable because the upper limit of the 95% confidence bands does not reach 0.50. This occurs in instances when not enough events have occurred to estimate the parameter.', 'groupId': 'OG005', 'lowerLimit': '24', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 5 years', 'description': 'Median (95% CI) time to death stratified by dose level and study part.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable Patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VEGF-R2 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1121.2', 'groupId': 'OG000', 'lowerLimit': '-1561.4', 'upperLimit': '-64.8'}, {'value': '-2249.7', 'groupId': 'OG001', 'lowerLimit': '-4385.4', 'upperLimit': '-764.1'}, {'value': '-2087.3', 'groupId': 'OG002', 'lowerLimit': '-3664.6', 'upperLimit': '-287.8'}, {'value': '-1287.1', 'groupId': 'OG003', 'lowerLimit': '-2192.0', 'upperLimit': '-702.5'}, {'value': '-1742.2', 'groupId': 'OG004', 'lowerLimit': '-3409.7', 'upperLimit': '-221.2'}, {'value': '-2519.4', 'groupId': 'OG005', 'lowerLimit': '-4412.9', 'upperLimit': '-465.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days', 'description': 'Median (Min, Max) of change for VEGF-R2 sample from baseline to the day 21 or 28 stratified by dose level and study part.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Toxicity evaluable patients'}, {'type': 'SECONDARY', 'title': 'Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'Number of patients with tumor markers CEA and/or calcitonin 2x ULN at baseline defined as CR (normalization of CEA or calcitonin) or PR (at least 50% decrease in CEA or CTN) at least 4 weeks apart.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes Medullary Thyroid Cancer (MTC) patients. The original protocol eligibility did not exclude Medullary Thyroid Cancer (MTC) patients from enrolling onto Part A . The exclusion was added with amendment 5A.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'FG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A Dose Level 1: 30 mg/m^2', 'description': 'Patients receive 30 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Part A Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Part A Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG003', 'title': 'Part B Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG004', 'title': 'Part PK Dose Level 2: 40 mg/m^2', 'description': 'Patients receive 40 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG005', 'title': 'Part PK Dose Level 3: 55 mg/m^2', 'description': 'Patients receive 55 mg/m\\^2 cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '18.0'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '4.0', 'upperLimit': '18.0'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '11.0', 'upperLimit': '18.0'}, {'value': '15', 'groupId': 'BG003', 'lowerLimit': '13.0', 'upperLimit': '17.0'}, {'value': '8.5', 'groupId': 'BG004', 'lowerLimit': '5.0', 'upperLimit': '17.0'}, {'value': '10.5', 'groupId': 'BG005', 'lowerLimit': '6.0', 'upperLimit': '15.0'}, {'value': '13', 'groupId': 'BG006', 'lowerLimit': '4.0', 'upperLimit': '18.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-31', 'size': 1575202, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-15T16:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-21', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-19', 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate', 'timeFrame': 'Up to 28 days', 'description': 'Maximum dose at which fewer than one-third of toxicity-evaluable patients experience a dose limiting toxicity during cycle 1 of therapy.'}, {'measure': 'Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib', 'timeFrame': 'Up to 28 days', 'description': 'Number of toxicity-evaluable patients who experience a dose limiting toxicity during cycle 1 of therapy stratified by dose level and study part.'}, {'measure': 'Clearance of Cabozantinib S-malate', 'timeFrame': 'Up to 24 hours', 'description': 'Median (min, max) clearance of cabozantinib stratified by dose level and study part post-dose in cycle 1, day 1.'}], 'secondaryOutcomes': [{'measure': 'Disease Response of Cabozantinib S-malate', 'timeFrame': 'Up to 5 years', 'description': 'Number of response-evaluable patients with response (CR or PR) determined by RECIST guideline (version 1.1) including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in sum of diameters of target lesions.'}, {'measure': 'Overall Survival (OS) of Cabozantinib S-malate', 'timeFrame': 'Up to 5 years', 'description': 'Median (95% CI) time to death stratified by dose level and study part.'}, {'measure': 'Change From Baseline in VEGF-R2 Concentration', 'timeFrame': 'Up to 28 days', 'description': 'Median (Min, Max) of change for VEGF-R2 sample from baseline to the day 21 or 28 stratified by dose level and study part.'}, {'measure': 'Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184', 'timeFrame': 'Up to 28 days', 'description': 'Number of patients with tumor markers CEA and/or calcitonin 2x ULN at baseline defined as CR (normalization of CEA or calcitonin) or PR (at least 50% decrease in CEA or CTN) at least 4 weeks apart.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Malignant Solid Neoplasm', 'Recurrent Melanoma', 'Recurrent Primary Central Nervous System Neoplasm', 'Recurrent Thyroid Gland Carcinoma', 'Refractory Malignant Solid Neoplasm', 'Refractory Primary Central Nervous System Neoplasm', 'Thyroid Gland Medullary Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of XL184 (cabozantinib) (cabozantinib S-malate) administered orally to children with refractory solid tumors including central nervous system (CNS) tumors.\n\nII. To define and describe the toxicities of XL184 (cabozantinib) administered on this schedule.\n\nIII. To characterize the pharmacokinetics of XL184 (cabozantinib) in children with refractory solid tumors.\n\nSECONDARY OBJECTIVES:\n\nI. To preliminarily define the antitumor activity of XL184 (cabozantinib) within the confines of a phase 1 study.\n\nII. To assess the biologic activity of XL184 (cabozantinib). III. To assess the biomarker response (carcinoembryonic antigen \\[CEA\\] and calcitonin) in patients with medullary thyroid cancer treated with XL184.\n\nIV. To evaluate overall survival from study entry through a five-year follow-up period.\n\nOUTLINE: This is a dose-escalation study. (Complete as of 4/16/2014)\n\nPatients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up at 30 days, 6 months, and then annually for up to 60 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have a body surface area \\>= 0.44 m\\^2 when enrolling on dose level -1; patients must have a body surface area \\>= 0.35 m\\^2 when enrolling on dose level 1, 2, or 3\n* PART A: Patients with relapsed or refractory solid tumors (excluding medullary thyroid cancer) including CNS tumors and malignant melanoma are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n* Part B: Patients with medullary thyroid cancer (MTC), with or without bone marrow involvement, will be eligible for Part B; these patients will be enrolled at dose level 2, the recommended phase 2 dose determined in the dose escalation part of the study\n* Patients must have either measurable or evaluable disease\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Karnofsky \\>= 50% for patients \\> 16 years of age and Lansky \\>= 50 for patients =\\< 16 years of age\n\n * Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy:\n\n * Myelosuppressive chemotherapy: at least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n * Hematopoietic growth factors: at least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\n * Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\n * Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\n * Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody\n * Radiation therapy (XRT): at least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if \\>= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation\n * Stem cell infusion without TBI: no evidence of active graft versus (vs.) host disease and at least 56 days must have elapsed after transplant or stem cell infusion\n* For patients with solid tumors without known bone marrow involvement:\n* Peripheral absolute neutrophil count (ANC) \\>= 1000/mm\\^3\n* Platelet count \\>= 100,000/mm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity in the dose-escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 ml/min/1.73 m\\^2 or a serum creatinine based on age/gender as follows:\n\n * 2 to \\< 6 years: 0.8 mg/dL\n * 6 to \\< 10 years: 1 mg/dL\n * 10 to \\< 13 years: 1.2 mg/dL\n * 13 to \\< 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\n * \\>= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)\n* Urine protein: =\\< 30 mg/dl in urinalysis or =\\< 1+ on dipstick, unless quantitative protein is \\< 1000 mg in a 24 hour (h) urine sample\n* Bilirubin (sum of conjugated + unconjugated) =\\< 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L\n* Serum albumin \\>= 2.8 g/dL\n* Prothrombin time (PT) and international normalized ratio (INR) =\\< 1.5 x ULN\n* Serum amylase =\\< 1.5 x ULN\n* Serum lipase =\\< 1.5 x ULN\n* A blood pressure (BP) =\\< the 95th percentile for age, height, and gender, and not receiving medication for treatment of hypertension; please note that 3 serial blood pressures should be obtained and averaged to determine baseline BP\n* Central nervous system function defined as: patients with seizure disorder may be enrolled if receiving non-enzyme inducing anticonvulsants and well controlled\n* No history of congenital prolonged corrected QT interval (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)\n* No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment\n* QTc =\\< 480 msec; Note: patients with grade 1 prolonged QTc (450-480 msec) at the time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e. electrolytes, medications)\n* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines\n* Archival tumor tissue slides from either initial diagnosis or relapse must be sent; if tumor tissue is unavailable, the study chair must be notified prior to enrollment\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use two methods of birth control - a medically accepted barrier method of contraceptive method (e.g., male or female condom) and a second effective contraceptive method of birth control - during protocol therapy and for at least 4 months after the last dose of XL184; abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients must not be receiving any of the following potent cytochrome P450 family 3, subfamily A, polypeptide 4 cytochrome (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort\n* Patients who are receiving systemic treatment anticoagulation are not eligible; patients receiving prophylactic systemic anticoagulation will be allowed as long as eligibility PT/INR requirements are met\n* Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment\n* Patients who are receiving drugs that prolong QTc are not eligible\n* Patients must be able to swallow intact tablets; patients who cannot swallow intact tablets are not eligible\n* Patients with active bleeding are not eligible; specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment\n* Patients with evidence of an acute intracranial or intratumoral hemorrhage on computed tomography (CT) or magnetic resonance imaging (MRI) are not eligible (patients with evidence of resolving hemorrhage will be eligible)\n* Patients who have had or are planning to have the following invasive procedures are not eligible:\n\n * Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\n * Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g. Hickman or Broviac) and at least 7 days prior to enrollment for subcutaneous port\n * Core biopsy within 7 days prior to enrollment\n * Fine needle aspirate within 7 days prior to enrollment\n * Surgical or other wounds must be adequately healed prior to enrollment\n* Patients on antihypertensive therapy for control of blood pressure at the time of enrollment are not eligible\n* Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of this oral agent are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible"}, 'identificationModule': {'nctId': 'NCT01709435', 'briefTitle': 'Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 1 Study of XL184 (Cabozantinib) in Children and Adolescents With Recurrent or Refractory Solid Tumors, Including CNS Tumors', 'orgStudyIdInfo': {'id': 'NCI-2012-01890'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01890', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'P121149'}, {'id': 'COG-ADVL1211'}, {'id': 'NCI-2013-01571'}, {'id': 'CDR0000741914'}, {'id': 'ADVL1211', 'type': 'OTHER', 'domain': 'Pediatric Early Phase Clinical Trial Network'}, {'id': 'ADVL1211', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UM1CA097452', 'link': 'https://reporter.nih.gov/quickSearch/UM1CA097452', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (cabozantinib S-malate)', 'description': 'Patients receive cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Cabozantinib S-malate', 'Other: Laboratory Biomarker Analysis', 'Other: Pharmacological Study']}], 'interventions': [{'name': 'Cabozantinib S-malate', 'type': 'DRUG', 'otherNames': ['BMS-907351', 'Cabometyx', 'Cometriq', 'XL-184', 'XL184'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (cabozantinib S-malate)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (cabozantinib S-malate)']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (cabozantinib S-malate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital-Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Oncology Group", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Meredith K Chuk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'COG Phase I Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}