Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-04 @ 1:14 PM
Study NCT ID:
NCT02761057
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2016-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'C558660', 'term': 'cabozantinib'}, {'id': 'D000077547', 'term': 'Crizotinib'}, {'id': 'C000593259', 'term': '1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mplets@fredhutch.org', 'phone': '2066674623', 'title': 'Genitourinary Committee Statistician', 'organization': 'SWOG Statistics and Data Management Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of treatment and follow up until death or 3 years post registration', 'description': '143 participants who received protocol treatment were evaluable for AEs: 45 on sunitinib arm, 43 on cabozantinib arm, 27 on crizotinib arm, and 28 on savolitinib arm. Adverse Events (AEs) are reported by CTCAE Version 4.0 and Serious Adverse Events (SAEs) are reported by CTCAE Version 5.0. All started participants were monitored/assessed for All-Cause Mortality".', 'eventGroups': [{'id': 'EG000', 'title': 'Sunitinib', 'description': 'Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Sunitinib Malate Given PO\n\nOther Names:\n\nSU011248 SU11248 sunitinib Sunitinib Malate Sutent', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 46, 'otherNumAffected': 44, 'seriousNumAtRisk': 45, 'deathsNumAffected': 24, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Cabozantinib', 'description': 'Experimental: Arm II (cabozantinib s-malate) Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Cabozantinib S-malate Given PO\n\nOther Names:\n\nBMS-907351 Cabometyx CABOZANTINIB S-MALATE Cometriq XL-184 XL184', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 44, 'otherNumAffected': 41, 'seriousNumAtRisk': 43, 'deathsNumAffected': 22, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Crizotinib', 'description': 'Experimental: Arm III (crizotinib closed to accrual 12/5/18) Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Crizotinib Given PO\n\nOther Names:\n\nCRIZOTINIB MET Tyrosine Kinase Inhibitor PF-02341066 PF-02341066 PF-2341066 Xalkori', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 28, 'otherNumAffected': 26, 'seriousNumAtRisk': 27, 'deathsNumAffected': 16, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Savolitinib', 'description': 'Experimental: Arm IV (savolitinib closed to accrual 12/5/18) Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Savolitinib Given PO\n\nOther Names:\n\nAZD 6094 AZD6094 HMPL-504 SAVOLITINIB Volitinib', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 29, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'deathsNumAffected': 21, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear and labyrinth disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flashing lights', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General disorders and admin site conditions - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 22}, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders-Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity\n\nDrug: Sunitinib Malate Given PO\n\nOther Names:\n\nSU011248 SU11248 sunitinib Sunitinib Malate Sutent'}, {'id': 'OG001', 'title': 'Cabozantinib', 'description': 'Experimental: Arm II (cabozantinib s-malate) Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Cabozantinib S-malate Given PO\n\nOther Names:\n\nBMS-907351 Cabometyx CABOZANTINIB S-MALATE Cometriq XL-184 XL184'}, {'id': 'OG002', 'title': 'Crizotinib', 'description': 'Experimental: Arm III (crizotinib closed to accrual 12/5/18) Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Crizotinib Given PO\n\nOther Names:\n\nCRIZOTINIB MET Tyrosine Kinase Inhibitor PF-02341066XXPF-02341066 PF-2341066 Xalkori'}, {'id': 'OG003', 'title': 'Savolitinib', 'description': 'Experimental: Arm IV (savolitinib closed to accrual 12/5/18) Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Savolitinib Given PO\n\nOther Names:\n\nAZD 6094 AZD6094 HMPL-504 SAVOLITINIB Volitinib'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '6.7'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '12.4'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '3.6'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '7.2'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.97', 'groupDescription': 'A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target lesions over smallest sum observed, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included eligible participants.'}, {'type': 'SECONDARY', 'title': 'Response Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity\n\nDrug: Sunitinib Malate Given PO\n\nOther Names:\n\nSU011248 SU11248 sunitinib Sunitinib Malate Sutent'}, {'id': 'OG001', 'title': 'Cabozantinib', 'description': 'Experimental: Arm II (cabozantinib s-malate) Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Cabozantinib S-malate Given PO\n\nOther Names:\n\nBMS-907351 Cabometyx CABOZANTINIB S-MALATE Cometriq XL-184 XL184'}, {'id': 'OG002', 'title': 'Crizotinib', 'description': 'Experimental: Arm III (crizotinib closed to accrual 12/5/18) Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Crizotinib Given PO\n\nOther Names:\n\nCRIZOTINIB MET Tyrosine Kinase Inhibitor PF-02341066XXPF-02341066 PF-2341066 Xalkori'}, {'id': 'OG003', 'title': 'Savolitinib', 'description': 'Experimental: Arm IV (savolitinib closed to accrual 12/5/18) Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Savolitinib Given PO\n\nOther Names:\n\nAZD 6094 AZD6094 HMPL-504 SAVOLITINIB Volitinib'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'groupId': 'OG000'}, {'value': '22.73', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'The response rate (RR) is defined as the combined rate of confirmed and unconfirmed partial response and confirmed and unconfirmed complete response. Complete response (CR) is defined as the complete disappearance of all target and non-target lesions, along with no new lesions. Partial response (PR) is defined as \\>=30% decrease of the sum of appropriate diameters of all target measurable lesions, along with no new lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included eligible participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity\n\nDrug: Sunitinib Malate Given PO\n\nOther Names:\n\nSU011248 SU11248 sunitinib Sunitinib Malate Sutent'}, {'id': 'OG001', 'title': 'Cabozantinib', 'description': 'Experimental: Arm II (cabozantinib s-malate) Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Cabozantinib S-malate Given PO\n\nOther Names:\n\nBMS-907351 Cabometyx CABOZANTINIB S-MALATE Cometriq XL-184 XL184'}, {'id': 'OG002', 'title': 'Crizotinib', 'description': 'Experimental: Arm III (crizotinib closed to accrual 12/5/18) Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Crizotinib Given PO\n\nOther Names:\n\nCRIZOTINIB MET Tyrosine Kinase Inhibitor PF-02341066XXPF-02341066 PF-2341066 Xalkori'}, {'id': 'OG003', 'title': 'Savolitinib', 'description': 'Experimental: Arm IV (savolitinib closed to accrual 12/5/18) Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Savolitinib Given PO\n\nOther Names:\n\nAZD 6094 AZD6094 HMPL-504 SAVOLITINIB Volitinib'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '21.6'}, {'value': '20.0', 'comment': 'There was not enough data to estimate the upper bound 95% CI', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': 'NA'}, {'value': '19.9', 'comment': 'There was not enough data to estimate the upper bound 95% CI', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': 'NA'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '6.7', 'upperLimit': '28.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.51', 'groupDescription': 'The log-rank test will be used to compare OS.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3 years', 'description': 'Duration from date of randomization to date of death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included eligible participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sunitinib', 'description': 'Experimental: Arm I (sunitinib malate) Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity\n\nDrug: Sunitinib Malate Given PO\n\nOther Names:\n\nSU011248 SU11248 sunitinib Sunitinib Malate Sutent'}, {'id': 'OG001', 'title': 'Cabozantinib', 'description': 'Experimental: Arm II (cabozantinib s-malate) Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Cabozantinib S-malate Given PO\n\nOther Names:\n\nBMS-907351 Cabometyx CABOZANTINIB S-MALATE Cometriq XL-184 XL184'}, {'id': 'OG002', 'title': 'Crizotinib', 'description': 'Experimental: Arm III (crizotinib closed to accrual 12/5/18) Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Crizotinib Given PO\n\nOther Names:\n\nCRIZOTINIB MET Tyrosine Kinase Inhibitor PF-02341066XXPF-02341066 PF-2341066 Xalkori'}, {'id': 'OG003', 'title': 'Savolitinib', 'description': 'Experimental: Arm IV (savolitinib closed to accrual 12/5/18) Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nDrug: Savolitinib Given PO\n\nOther Names:\n\nAZD 6094 AZD6094 HMPL-504 SAVOLITINIB Volitinib'}], 'classes': [{'title': 'Abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Acute kidney injury', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Allergic reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Back pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dehydration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Duodenal ulcer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Edema limbs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Facial pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Febrile neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal disorders - Other, specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Generalized muscle weakness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Genital edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hearing impaired', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypercalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypermagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypocalcemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypomagnesemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Hypophosphatemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hypoxia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Infections and infestations - Other, specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lung infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte count increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Mucositis oral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Muscle weakness lower limb', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Nervous system disorders - Other, specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophil count decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pain in extremity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Palmar-plantar erythrodysesthesia syndrome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pancreatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Paronychia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pleural effusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Proteinuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Rash maculo-papular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Renal calculi', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Reproductive system and breast disorders - Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sinus bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sinus tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Skin ulceration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Thromboembolic event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Thrombotic thrombocytopenic purpura', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vascular disorders - Other, specify', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'White blood cell decreased', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of treatment and follow up until death or 3 years post registration', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants who received at least one dose of protocol treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MET Mutation Rate', 'timeFrame': 'Up to 3 years', 'description': 'The hazard ratio between the MET inhibitor versus (vs.) sunitinib in those with versus without the mutation (i.e., the interaction) will be compared. Response Evaluation Criteria in Solid Tumors (RECIST) response rate (confirmed and unconfirmed partial response and complete response) based on MET mutation/expression level will be compared using the chi-square test.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Sunitinib Malate)', 'description': 'Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nSunitinib Malate: Given PO'}, {'id': 'FG001', 'title': 'Arm II (Cabozantinib S-malate)', 'description': 'Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nCabozantinib S-malate: Given PO'}, {'id': 'FG002', 'title': 'Arm III (Crizotinib Closed to Accrual 12/5/18)', 'description': 'Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nCrizotinib: Given PO'}, {'id': 'FG003', 'title': 'Arm IV (Savolitinib Closed to Accrual 12/5/18)', 'description': 'Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nSavolitinib: Given PO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'Received Protocol Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Ineligible - No Measurable Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Ineligible - Inadequate Baseline Disease Assessment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Currently On Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Refusal Unrelated to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Progression/Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other - Not Protocol Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '152 participants were enrolled and randomly assigned. Five participants were excluded because of inadequate baseline disease assessment or no evidence of metastatic disease. Therefore, 147 were deemed eligible and analyzable for the primary analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Sunitinib Malate)', 'description': 'Patients receive sunitinib malate PO on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nSunitinib Malate: Given PO'}, {'id': 'BG001', 'title': 'Arm II (Cabozantinib S-malate)', 'description': 'Patients receive cabozantinib s-malate PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nCabozantinib S-malate: Given PO'}, {'id': 'BG002', 'title': 'Arm III (Crizotinib Closed to Accrual 12/5/18)', 'description': 'Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nCrizotinib: Given PO'}, {'id': 'BG003', 'title': 'Arm IV (Savolitinib Closed to Accrual 12/5/18)', 'description': 'Patients receive savolitinib PO on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity.\n\nSavolitinib: Given PO'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '73'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '58', 'upperLimit': '75'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '75'}, {'value': '67', 'groupId': 'BG003', 'lowerLimit': '58', 'upperLimit': '72'}, {'value': '66', 'groupId': 'BG004', 'lowerLimit': '58', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], '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': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Systemic Therapy', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histological Subtype (Local Assessment)', 'classes': [{'categories': [{'title': 'Type 1', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}, {'title': 'Type 2', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}, {'title': 'Not otherwise specified', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Papillary renal cell carcinoma (pRCC) histological subtype as determined by a local pathologist. Type 1 is characterized by small cells in a a single layer with scant basophilic cytoplasm and oval nuclei. Type 2 is characterized by large cells with eosinophilic cytoplasm and spherical nuclei with prominent nucleoli and pseudostratification. Type 1 is more common and grows slowly and type 2 is more aggressive and grows more quickly. In general, type 2 pRCC has a poorer prognosis than type 1.', 'unitOfMeasure': 'Participants'}, {'title': 'Histological Subtype (Central Assessment)', 'classes': [{'categories': [{'title': 'Type 1', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Type 2', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'Mixed or Other', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Papillary renal cell carcinoma (pRCC) histological subtype as determined by a central pathologic assessment. Type 1 is characterized by small cells in a a single layer with scant basophilic cytoplasm and oval nuclei. Type 2 is characterized by large cells with eosinophilic cytoplasm and spherical nuclei with prominent nucleoli and pseudostratification. Type 1 is more common and grows slowly and type 2 is more aggressive and grows more quickly. In general, type 2 pRCC has a poorer prognosis than type 1.', 'unitOfMeasure': 'Participants'}, {'title': 'IMDC Risk Group', 'classes': [{'categories': [{'title': 'Favourable', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Intermediate', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}, {'title': 'High', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The International Metastatic Renal Cell Carcinoma Database Consortium's (IMDC) prognostic model to predict survival of metastatic kidney cancer patients has become the standard model used in clinical trials to categorize patients into favorable, intermediate, and poor risk based on treatment time, performance status, and hemoglobin, calcium, neutrophil, and platelet counts.", 'unitOfMeasure': 'Participants'}, {'title': 'Zubrod Performance Score', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}, {'title': '1', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Zubrod performance status scores range from 0 to 4, with higher scores reflecting greater disability. This study only includes participants with a score of 0-1.\n\n0: Fully active, able to carry on all pre-disease performance without restriction.\n\n1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Nephrectomy', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Metastatic Sites of Interest', 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}, {'title': 'CNS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included only eligible participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-15', 'size': 2565422, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-06T12:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2016-05-02', 'resultsFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-02', 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MET Mutation Rate', 'timeFrame': 'Up to 3 years', 'description': 'The hazard ratio between the MET inhibitor versus (vs.) sunitinib in those with versus without the mutation (i.e., the interaction) will be compared. Response Evaluation Criteria in Solid Tumors (RECIST) response rate (confirmed and unconfirmed partial response and complete response) based on MET mutation/expression level will be compared using the chi-square test.'}], 'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 3 years', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target lesions over smallest sum observed, or a measurable increase in a non-target lesion, or the appearance of new lesions'}], 'secondaryOutcomes': [{'measure': 'Response Rate (RR)', 'timeFrame': 'Up to 3 years', 'description': 'The response rate (RR) is defined as the combined rate of confirmed and unconfirmed partial response and confirmed and unconfirmed complete response. Complete response (CR) is defined as the complete disappearance of all target and non-target lesions, along with no new lesions. Partial response (PR) is defined as \\>=30% decrease of the sum of appropriate diameters of all target measurable lesions, along with no new lesions.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 3 years', 'description': 'Duration from date of randomization to date of death from any cause.'}, {'measure': 'Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs', 'timeFrame': 'Duration of treatment and follow up until death or 3 years post registration', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Locally Advanced Papillary Renal Cell Carcinoma', 'Metastatic Papillary Renal Cell Carcinoma', 'Stage III Renal Cell Cancer AJCC v7', 'Stage IV Renal Cell Cancer AJCC v7', 'Type 1 Papillary Renal Cell Carcinoma', 'Type 2 Papillary Renal Cell Carcinoma', 'Unresectable Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39255440', 'type': 'DERIVED', 'citation': 'Barata P, Tangen C, Plets M, Thompson IM Jr, Narayan V, George DJ, Heng DYC, Shuch B, Stein M, Gulati S, Tretiakova M, Tripathi A, Bjarnason GA, Humphrey P, Adeniran A, Vaishampayan U, Alva A, Zhang T, Cole S, Lara PN Jr, Lerner SP, Balzer-Haas N, Pal SK. Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. J Clin Oncol. 2024 Nov 20;42(33):3911-3916. doi: 10.1200/JCO.24.00767. Epub 2024 Sep 10.'}, {'pmid': '37146227', 'type': 'DERIVED', 'citation': 'Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.'}, {'pmid': '33592176', 'type': 'DERIVED', 'citation': 'Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. doi: 10.1016/S0140-6736(21)00152-5. Epub 2021 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'This phase II trial studies how well cabozantinib s-malate, crizotinib, savolitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib s-malate, crizotinib, savolitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving cabozantinib s-malate, crizotinib, or savolitinib will work better in treating patients with kidney cancer compared to sunitinib malate.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare progression-free survival (PFS) in patients with metastatic papillary renal cell carcinoma (mPRCC) treated with sunitinib malate (sunitinib) to PFS in patients with mPRCC treated with MET kinase inhibitors.\n\nSECONDARY OBJECTIVES:\n\nI. To compare Response Evaluation Criteria in Solid Tumors (RECIST) response rate (RR; defined as the combined rate of confirmed and unconfirmed partial response \\[PR\\] and confirmed and unconfirmed complete response \\[CR\\]) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors.\n\nII. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors.\n\nIII. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC.\n\nTRANSLATIONAL OBJECTIVES:\n\nI. To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors.\n\nII. To estimate the frequency of high oncometabolite levels in formalin-fixed, paraffin-embedded (FFPE) tissues of patients with advanced papillary renal cell carcinoma by liquid chromatography-mass spectrometry (LC-MS/MS) and estimate progression free survival for those with and without high oncometabolite levels being treated.\n\nIII. To correlate the mutational signature suggestive of a homologous recombination defect with high oncometabolite levels in patients with papillary renal cell carcinoma pRCC.\n\nOUTLINE: Patients are randomized to 1 of 4 treatment arms. As of 12/5/18, patients will only be randomized to Arm I or Arm II.\n\nARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.\n\nARM II: Patients receive cabozantinib s-malate PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.\n\nARM III (CLOSED TO ACCRUAL 12/5/18): Patients receive crizotinib PO twice daily (BID) on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.\n\nARM IV (CLOSED TO ACCRUAL 12/5/18): Patients receive savolitinib PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.\n\nAfter completion of study treatment, patients are followed up for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain \\>= 50% of the papillary component\n* Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment form\n* Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin)\n* Patients must not have cavitating pulmonary lesions; patients must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration\n* Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery\n* Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced renal cell carcinoma (RCC) (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC; if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registration\n* Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 14 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration\n* Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution\n* Patients must not be receiving or planning to receive any other investigational agents\n* Patients must have a complete physical examination and medical history within 28 days prior to registration\n* Patients must have a Zubrod performance status of 0 - 1\n* White blood cell count (WBC) \\>= 2,000/mcL (must be obtained within 28 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1,000/mcL (must be obtained within 28 days prior to registration)\n* Platelet count \\>= 75,000/mcL (must be obtained within 28 days prior to registration)\n* Serum bilirubin =\\< 1.5 x institutional upper limits of normal (ULN) (must be obtained within 28 days prior to registration)\n* Serum transaminase (serum glutamic oxaloacetic transaminase \\[SGOT\\]/aspartate aminotransferase \\[AST\\] and serum glutamate pyruvate transaminase \\[SGPT\\]/alanine aminotransferase \\[ALT\\]) must be =\\< 2.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =\\< 5 x the institutional ULN (must be obtained within 28 days prior to registration)\n* Serum creatinine must be =\\< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) must be \\> 30 mL/min (must be obtained within 28 days prior to registration)\n* Patients must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association \\[NYHA\\] class III \\[moderate\\] or class IV \\[severe\\]) at the time of registration; baseline echocardiogram within 28 days of registration must demonstrate an ejection fraction (EF) \\>= 50%; due to the potential cardiac toxicity of the agents utilized in this protocol, patients must have corrected QT (QTc) interval \\< 500 msec on prestudy electrocardiogram (EKG) and no known history of congenital long QT syndrome; patients must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack \\[TIA\\] or other ischemic event) within 3 months prior to registration and not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 6 months of registration; prestudy EKG must be obtained within 28 days prior to registration\n* Baseline urinalysis should show urine protein \\< 3+ and must be obtained within 28 days prior to registration; if urine protein is 3+ or greater, then urine protein by 24 hour collection must show less than 3 grams of protein\n* Patients must not have inadequately controlled hypertension; patients must have documented blood pressures of systolic blood pressure (SBP) \\< 150 and diastolic blood pressure (DBP) \\< 90 within 14 days of starting randomization; blood pressure medications (any number) are permitted\n* Patients must be able to take oral medications (i.e., swallow pills whole); patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible\n* Patients must not have had any clinically-significant GI bleeding within 6 months prior to registration and patients must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula; examples of this include (but are not limited to) Crohn\'s disease or tumor with transmural extension through the gastrointestinal lining\n* Patients must not have had hemoptysis of \\>= 0.5 teaspoon (2.5 ml) of red blood within 3 months prior registration\n* Patients must not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior to registration\n* Patient\'s baseline imaging must not indicate the presence of tumor invading or encasing any major blood vessels\n* Patients must not have any unresolved wounds from previous surgery\n* Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within 28 days of registration\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years; men receiving active surveillance for prostate cancer may also be enrolled\n* Due to the unknown effects of the study drugs, patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for three months after last dose of study drug; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures\n* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cabozantinib, crizotinib, savolitinib or sunitinib; in addition these patients are at increased risk of lethal infections when treated with marrow suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated\n* Patients must be \\>= 18 years of age\n* Patients must have tissue available and be willing to submit for independent pathologic review in order to classify type I versus type II papillary disease\n* Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines\n* As a part of the OPEN registration process the treating institution\'s identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system'}, 'identificationModule': {'nctId': 'NCT02761057', 'briefTitle': 'Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)', 'orgStudyIdInfo': {'id': 'NCI-2015-01707'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01707', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'S1500', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'S1500', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180888', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180888', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (sunitinib malate)', 'description': 'Patients receive sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Drug: Sunitinib Malate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (cabozantinib s-malate)', 'description': 'Patients receive cabozantinib s-malate PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Drug: Cabozantinib S-malate', 'Procedure: Computed Tomography']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (crizotinib closed to accrual 12/5/18)', 'description': 'Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Drug: Crizotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm IV (savolitinib closed to accrual 12/5/18)', 'description': 'Patients receive savolitinib PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Procedure: Computed Tomography', 'Drug: Savolitinib']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of plasma and serum samples', 'armGroupLabels': ['Arm I (sunitinib malate)', 'Arm II (cabozantinib s-malate)', 'Arm III (crizotinib closed to accrual 12/5/18)', 'Arm IV (savolitinib closed to accrual 12/5/18)']}, {'name': 'Bone Scan', 'type': 'PROCEDURE', 'otherNames': ['Bone Scintigraphy'], 'description': 'Undergo bone scan', 'armGroupLabels': ['Arm I (sunitinib malate)', 'Arm II (cabozantinib s-malate)', 'Arm III (crizotinib closed to accrual 12/5/18)', 'Arm IV (savolitinib closed to accrual 12/5/18)']}, {'name': 'Cabozantinib S-malate', 'type': 'DRUG', 'otherNames': ['BMS-907351', 'Cabometyx', 'Cometriq', 'XL 184', 'XL-184', 'XL184'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (cabozantinib s-malate)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Arm I (sunitinib malate)', 'Arm II (cabozantinib s-malate)', 'Arm III (crizotinib closed to accrual 12/5/18)', 'Arm IV (savolitinib closed to accrual 12/5/18)']}, {'name': 'Crizotinib', 'type': 'DRUG', 'otherNames': ['Alkixen', 'Crizocent', 'MET Tyrosine Kinase Inhibitor PF-02341066', 'PF 02341066', 'PF-02341066', 'PF-2341066', 'PF02341066', 'Xalkori'], 'description': 'Given PO', 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