Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT01136733
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2010-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment
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': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-888-422-4743', 'title': 'Eisai Medical Services', 'organization': 'Eisai Medical Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (AEs) were collected and defined as those AEs that occurred after the first dose of study medication and up to 30 days after the last dose of study medication. AEs were collected for approximately 4 years.', 'description': 'Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 9, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 51, 'seriousNumAtRisk': 51, 'deathsNumAffected': 43, 'seriousNumAffected': 30}, {'id': 'EG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 51, 'seriousNumAtRisk': 52, 'deathsNumAffected': 40, 'seriousNumAffected': 28}, {'id': 'EG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 45, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhagic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ventricular Hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Inappropriate Antidiuretic Hormone Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anorectal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aphthous Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 43}, {'groupId': 'EG005', 'numAtRisk': 52, 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[{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pathological Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Spinal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Malignant Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Carotid Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'title': 'Grade 3 abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2 fatigue with Grade 1 GI reflux & anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2 stomatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)', 'description': 'A DLT was defined as either a treatment-related failure to administer greater than or equal to (\\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \\>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: Dose Escalation and MTD Expansion Cohorts', 'description': 'Oral everolimus (18 mg) and lenvatinib (5 mg) were taken once daily in the morning (consistently with or without food) with water. Any dietary habits around the time of study medication intake had to be kept as consistent as possible throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)', 'description': 'The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.', 'unitOfMeasure': 'mg/day', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG004', 'lowerLimit': '5.9', 'upperLimit': '20.1'}, {'value': '7.4', 'groupId': 'OG005', 'lowerLimit': '5.6', 'upperLimit': '10.2'}, {'value': '5.5', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '7.1'}]}]}], 'analyses': [{'pValue': '=0.0005', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.68', 'estimateComment': 'Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.', 'groupDescription': 'Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0479', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.98', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1209', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.39', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months', 'description': 'PFS was defined as the time (in months) from the date of first dose of study drug to the first documentation of disease progression or death, whichever occurred first. Kaplan-Meier (K-M) estimates were used to estimate median PFS, presented with 2-sided 95% confidence intervals (CIs). Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease using computed tomography (CT) or magnetic resonance imaging (MRI) and scan acquisition techniques (including use or nonuse of intravenous (IV) contrast). Tumor response was determined at the site by the investigator and radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the evaluation of the tumor assessment scans. The date of objective disease progression was defined as the earliest date of radiological disease progression. Participants removed from therapy due to clinical progression with no radiologic confirmation were censored at their last radiologic assessment date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'comment': 'NA = not estimable', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': 'NA'}, {'value': '19.1', 'groupId': 'OG005', 'lowerLimit': '13.6', 'upperLimit': '26.2'}, {'value': '15.4', 'groupId': 'OG006', 'lowerLimit': '11.8', 'upperLimit': '19.6'}]}]}], 'analyses': [{'pValue': '=0.0242', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.514', 'ciLowerLimit': '0.299', 'ciUpperLimit': '0.884', 'estimateComment': 'Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.', 'groupDescription': 'Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '=0.1181', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.684', 'ciLowerLimit': '0.411', 'ciUpperLimit': '1.138', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '=0.3157', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.751', 'ciLowerLimit': '0.433', 'ciUpperLimit': '1.301', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Cycle 1 Day 1) until date of death from any cause, assessed up to the data cutoff date (10 Dec 2014), up to approximately 2 years and 9 months', 'description': 'OS was defined as the time (in months) from the date of randomization until date of death from any cause. Median survival time was calculated using K-M estimate for each treatment arm and presented with 2-sided 95% CIs. Participants who were lost to follow-up or alive at the data cutoff date (10 Dec 2014) were censored at the date the participants were last known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG004', 'lowerLimit': '29.3', 'upperLimit': '57.8'}, {'value': '26.9', 'groupId': 'OG005', 'lowerLimit': '15.6', 'upperLimit': '41.0'}, {'value': '6.0', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '16.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG004', 'OG006'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '2.3', 'ciUpperLimit': '22.5', 'pValueComment': "Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.", 'estimateComment': 'Rate ratio was based on the normal approximation.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0067', 'groupIds': ['OG005', 'OG006'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '1.4', 'ciUpperLimit': '14.7', 'pValueComment': "Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '=0.1007', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.9', 'ciUpperLimit': '2.8', 'pValueComment': "Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Cycle 1 Day 1) until first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The ORR was defined as the percentage of participants who had the best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator, using RECIST 1.1 in the evaluation of MRI or CT scans of targeted lesions. Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease). The BOR was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR was calculated with exact 95% CIs using the method of Clopper and Pearson.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day withwater, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG004', 'lowerLimit': '71.4', 'upperLimit': '93.0'}, {'value': '78.8', 'groupId': 'OG005', 'lowerLimit': '65.3', 'upperLimit': '88.9'}, {'value': '68.0', 'groupId': 'OG006', 'lowerLimit': '53.3', 'upperLimit': '80.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The DCR was defined as the percentage of participants who had a BOR of CR or PR or SD (minimum duration from randomization to SD greater than or equal to 7 weeks). Assessments were performed every 8 weeks and were based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD greater than or equal to 7 weeks.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Durable Stable Disease (SD) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG004', 'lowerLimit': '14.3', 'upperLimit': '39.6'}, {'value': '38.5', 'groupId': 'OG005', 'lowerLimit': '25.3', 'upperLimit': '53.0'}, {'value': '36.0', 'groupId': 'OG006', 'lowerLimit': '22.9', 'upperLimit': '50.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The durable SD rate was defined as the percentage of participants whose BOR was SD and the duration of SD was greater than or equal to 23 weeks. The durable SD was based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '52', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'OG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'OG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'OG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'OG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG004', 'lowerLimit': '54.1', 'upperLimit': '80.9'}, {'value': '65.4', 'groupId': 'OG005', 'lowerLimit': '50.9', 'upperLimit': '78.0'}, {'value': '42.0', 'groupId': 'OG006', 'lowerLimit': '28.2', 'upperLimit': '56.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (duration of SD was greater than or equal to 23 weeks) and was based on investigator review data using RECIST 1.1. The BOR was defined as the best response recorded from the start of study treatment until discontinuation from the study. There was no requirement for confirmatory measurement of PR or CR to deem either one the BOR. The 95% CI was constructed using the method of Clopper and Pearson. CBR = CR + PR + SD greater than or equal to 23 weeks.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set which included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Summary of Plasma Concentrations of Lenvatinib for Sparse Pharmacokinetic (PK) Sampling for Phase 1b and Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG001', 'title': 'Cycle 1, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}, {'id': 'OG002', 'title': 'Cycle 2, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG003', 'title': 'Cycle 2, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}, {'id': 'OG004', 'title': 'Cycle 3, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG005', 'title': 'Cycle 3, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '197', 'spread': '140', 'groupId': 'OG001'}, {'value': '66.9', 'spread': '52.7', 'groupId': 'OG002'}, {'value': '237', 'spread': '154', 'groupId': 'OG003'}, {'value': '37.0', 'spread': '35.5', 'groupId': 'OG004'}, {'value': '180', 'spread': '118', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)', 'description': 'Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Plasma concentrations of lenvatinib were measured and concentration data were summarized. The summary statistics at time points with one or more below the limit of quantitation (BLQ) values were calculated by assigning zero for each BLQ value.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who have received at least one dose of study drug (lenvatinib or everolimus) and have evaluable concentration data.'}, {'type': 'SECONDARY', 'title': 'Summary of Blood Concentrations of Everolimus for Sparse PK Sampling for Phase 1b and Phase 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG001', 'title': 'Cycle 1, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}, {'id': 'OG002', 'title': 'Cycle 2, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG003', 'title': 'Cycle 2, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}, {'id': 'OG004', 'title': 'Cycle 3, Day 1 (0 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.'}, {'id': 'OG005', 'title': 'Cycle 3, Day 1 (2-8 Hours)', 'description': 'Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '9.16', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '7.28', 'groupId': 'OG002'}, {'value': '24.3', 'spread': '14.2', 'groupId': 'OG003'}, {'value': '6.8', 'spread': '6.06', 'groupId': 'OG004'}, {'value': '26.4', 'spread': '14.8', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)', 'description': 'Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Whole blood concentrations of everolimus were measured and concentration data were summarized. The summary statistics at time points with one or more BLQ values were calculated by assigning zero for each BLQ value.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all participants who received at least one dose of study drug (lenvatinib or everolimus) and had evaluable concentration data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC(0-24)) for Lenvatinib When Administered Alone or in Combination With Everolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '3185', 'spread': '1030', 'groupId': 'OG000'}, {'value': '5252', 'spread': '2717', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)', 'description': 'Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for lenvatinib were derived from lenvatinib concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic sub analysis set consisted of all participants who agreed to participate in the intensive PK sampling portion of Phase 2 of the study, had received at least 1 dose of study drug (lenvatinib or everolimus), and had evaluable concentration data.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Lenvatinib in Plasma When Administered Alone or in Combination With Everolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '327', 'spread': '179', 'groupId': 'OG000'}, {'value': '403', 'spread': '165', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Cmax for lenvatinib was defined as the maximum observed concentration of lenvatinib in plasma following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured plasma concentration-time curves.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sub analysis set'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) for Lenvatinib When Administered Alone or in Combination With Everolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '8.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Tmax for lenvatinib was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach maximum concentration (Cmax) of lenvatinib in plasma.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sub analysis set'}, {'type': 'SECONDARY', 'title': 'Area Under the Blood Concentration-Time Curve From 0 to 24 Hours for Everolimus When Administered Alone or in Combination With Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '378', 'spread': '88.1', 'groupId': 'OG000'}, {'value': '463', 'spread': '263', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)', 'description': 'Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for everolimus were derived from everolimus concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sub analysis set. n=8 for AUC(0-24)'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration of Everolimus (Cmax) in Blood When Administered Alone or in Combination With Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '54', 'spread': '24.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Cmax for everolimus was defined as the maximum observed concentration of everolimus in blood following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured blood concentration-time curves.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sub analysis set'}, {'type': 'SECONDARY', 'title': 'Time to Cmax (Tmax) for Everolimus When Administered Alone or in Combination With Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 18 mg Lenvatinib + 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'OG001', 'title': 'Phase 2: 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '25.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Tmax for everolimus was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach the maximum concentration (Cmax) of everolimus in blood.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK sub analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'FG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'FG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'FG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'FG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'FG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'FG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}], 'periods': [{'title': 'Phase 1b', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants in Phase 1b did not advance to Phase 2.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Participants in Phase 1b did not advance to Phase 2.', 'groupId': 'FG001', 'numSubjects': '11'}, {'comment': 'Participants in Phase 1b did not advance to Phase 2.', 'groupId': 'FG002', 'numSubjects': '2'}, {'comment': 'Participants in Phase 1b did not advance to Phase 2.', 'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Participant Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Administrative-Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants in Phase 2 did not participate in Phase 1b.', 'groupId': 'FG004', 'numSubjects': '51'}, {'comment': 'Participants in Phase 2 did not participate in Phase 1b.', 'groupId': 'FG005', 'numSubjects': '52'}, {'comment': 'Participants in Phase 2 did not participate in Phase 1b.', 'groupId': 'FG006', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '52'}, {'groupId': 'FG006', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '30'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Participant Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Administrative-Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'A total of 173 participants were enrolled into the study and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}, {'value': '173', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.'}, {'id': 'BG001', 'title': 'Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'BG002', 'title': 'Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.'}, {'id': 'BG003', 'title': 'Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus', 'description': 'The DLT was achieved and no participants were enrolled into this cohort.'}, {'id': 'BG004', 'title': 'Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus', 'description': 'Oral lenvatinib (18 mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.'}, {'id': 'BG005', 'title': 'Phase 2 (Arm B): 24 mg Lenvatinib', 'description': 'Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'BG006', 'title': 'Phase 2 (Arm C): 10 mg Everolimus', 'description': 'Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Phase 1b', 'categories': [{'measurements': [{'value': '58.0', 'spread': '3.92', 'groupId': 'BG000'}, {'value': '58.1', 'spread': '7.97', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '2.83', 'groupId': 'BG002'}, {'value': '0', 'spread': '0', 'groupId': 'BG004'}, {'value': '0', 'spread': '0', 'groupId': 'BG005'}, {'value': '0', 'spread': '0', 'groupId': 'BG006'}, {'value': '58.4', 'spread': '6.29', 'groupId': 'BG007'}]}]}, {'title': 'Phase 2', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'BG000'}, {'value': '0', 'spread': '0', 'groupId': 'BG001'}, {'value': '0', 'spread': '0', 'groupId': 'BG002'}, {'value': '61.7', 'spread': '8.2', 'groupId': 'BG004'}, {'value': '63.3', 'spread': '8.6', 'groupId': 'BG005'}, {'value': '58.9', 'spread': '9.2', 'groupId': 'BG006'}, {'value': '61.3', 'spread': '8.8', 'groupId': 'BG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '47', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '126', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2010-05-26', 'dispFirstSubmitQcDate': '2016-04-18', 'resultsFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2010-06-02', 'dispFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-07', 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT)', 'timeFrame': 'First dose of study drug (Cycle 1 Day 1) to end of first 4 weeks of therapy (Cycle 1)', 'description': 'A DLT was defined as either a treatment-related failure to administer greater than or equal to (\\>=) 75% of the planned dosage of lenvatinib/everolimus or a specific National Cancer Institute Common Toxicity Criteria (NCI CTC) \\>= Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care daily living activities) hematologic or nonhematologic toxicities considered to be possibly related to lenvatinib and/or everolimus therapy assessed during the first treatment cycle of each dose level. Higher grade indicates more severe toxicity.'}, {'measure': 'Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose', 'timeFrame': 'First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)', 'description': 'The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.'}, {'measure': 'Phase 2: Progression-Free Survival (PFS)', 'timeFrame': 'Date of randomization into Phase 2 (Cycle 1 Day 1) to the date of first documentation of disease progression or death (whichever occurred first), assessed up to data cutoff date (13 Jun 2014), up to approximately 2 years and 3 months', 'description': 'PFS was defined as the time (in months) from the date of first dose of study drug to the first documentation of disease progression or death, whichever occurred first. Kaplan-Meier (K-M) estimates were used to estimate median PFS, presented with 2-sided 95% confidence intervals (CIs). Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease using computed tomography (CT) or magnetic resonance imaging (MRI) and scan acquisition techniques (including use or nonuse of intravenous (IV) contrast). Tumor response was determined at the site by the investigator and radiologist using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the evaluation of the tumor assessment scans. The date of objective disease progression was defined as the earliest date of radiological disease progression. Participants removed from therapy due to clinical progression with no radiologic confirmation were censored at their last radiologic assessment date.'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'Randomization (Cycle 1 Day 1) until date of death from any cause, assessed up to the data cutoff date (10 Dec 2014), up to approximately 2 years and 9 months', 'description': 'OS was defined as the time (in months) from the date of randomization until date of death from any cause. Median survival time was calculated using K-M estimate for each treatment arm and presented with 2-sided 95% CIs. Participants who were lost to follow-up or alive at the data cutoff date (10 Dec 2014) were censored at the date the participants were last known to be alive.'}, {'measure': 'Phase 2: Objective Response Rate (ORR)', 'timeFrame': 'Randomization (Cycle 1 Day 1) until first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The ORR was defined as the percentage of participants who had the best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator, using RECIST 1.1 in the evaluation of MRI or CT scans of targeted lesions. Tumor assessments were performed every 8 weeks (or sooner if there was evidence of progressive disease). The BOR was defined as the best response recorded from the start of the study treatment until discontinuation from the study. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR was calculated with exact 95% CIs using the method of Clopper and Pearson.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The DCR was defined as the percentage of participants who had a BOR of CR or PR or SD (minimum duration from randomization to SD greater than or equal to 7 weeks). Assessments were performed every 8 weeks and were based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD greater than or equal to 7 weeks.'}, {'measure': 'Durable Stable Disease (SD) Rate', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The durable SD rate was defined as the percentage of participants whose BOR was SD and the duration of SD was greater than or equal to 23 weeks. The durable SD was based on investigator review data using RECIST 1.1. The 95% CI was constructed using the method of Clopper and Pearson.'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Baseline (Randomization) to first evidence of disease progression, assessed up to the data cutoff date (13 Jun 2014), or up to approximately 2 years and 3 months', 'description': 'The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (duration of SD was greater than or equal to 23 weeks) and was based on investigator review data using RECIST 1.1. The BOR was defined as the best response recorded from the start of study treatment until discontinuation from the study. There was no requirement for confirmatory measurement of PR or CR to deem either one the BOR. The 95% CI was constructed using the method of Clopper and Pearson. CBR = CR + PR + SD greater than or equal to 23 weeks.'}, {'measure': 'Summary of Plasma Concentrations of Lenvatinib for Sparse Pharmacokinetic (PK) Sampling for Phase 1b and Phase 2', 'timeFrame': 'Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)', 'description': 'Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Plasma concentrations of lenvatinib were measured and concentration data were summarized. The summary statistics at time points with one or more below the limit of quantitation (BLQ) values were calculated by assigning zero for each BLQ value.'}, {'measure': 'Summary of Blood Concentrations of Everolimus for Sparse PK Sampling for Phase 1b and Phase 2', 'timeFrame': 'Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)', 'description': 'Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Whole blood concentrations of everolimus were measured and concentration data were summarized. The summary statistics at time points with one or more BLQ values were calculated by assigning zero for each BLQ value.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC(0-24)) for Lenvatinib When Administered Alone or in Combination With Everolimus', 'timeFrame': 'Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)', 'description': 'Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for lenvatinib were derived from lenvatinib concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.'}, {'measure': 'Maximum Concentration (Cmax) of Lenvatinib in Plasma When Administered Alone or in Combination With Everolimus', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Cmax for lenvatinib was defined as the maximum observed concentration of lenvatinib in plasma following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured plasma concentration-time curves.'}, {'measure': 'Time to Cmax (Tmax) for Lenvatinib When Administered Alone or in Combination With Everolimus', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Tmax for lenvatinib was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach maximum concentration (Cmax) of lenvatinib in plasma.'}, {'measure': 'Area Under the Blood Concentration-Time Curve From 0 to 24 Hours for Everolimus When Administered Alone or in Combination With Lenvatinib', 'timeFrame': 'Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)', 'description': 'Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for everolimus were derived from everolimus concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.'}, {'measure': 'Maximum Concentration of Everolimus (Cmax) in Blood When Administered Alone or in Combination With Lenvatinib', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Cmax for everolimus was defined as the maximum observed concentration of everolimus in blood following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured blood concentration-time curves.'}, {'measure': 'Time to Cmax (Tmax) for Everolimus When Administered Alone or in Combination With Lenvatinib', 'timeFrame': 'Phase 2: Cycle 1 Day 15', 'description': 'Tmax for everolimus was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach the maximum concentration (Cmax) of everolimus in blood.'}]}, 'conditionsModule': {'keywords': ['Unresectable advanced or metastatic renal cell carcinoma'], 'conditions': ['Metastatic Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '33024271', 'type': 'DERIVED', 'citation': 'Lee CH, Motzer RJ, Glen H, Michaelson MD, Larkin J, Minoshima Y, Kanekiyo M, Ikezawa H, Sachdev P, Dutcus CE, Funahashi Y, Voss MH. Correlative serum biomarker analyses in the phase 2 trial of lenvatinib-plus-everolimus in patients with metastatic renal cell carcinoma. Br J Cancer. 2021 Jan;124(1):237-246. doi: 10.1038/s41416-020-01092-0. Epub 2020 Oct 7.'}, {'pmid': '26482279', 'type': 'DERIVED', 'citation': 'Motzer RJ, Hutson TE, Glen H, Michaelson MD, Molina A, Eisen T, Jassem J, Zolnierek J, Maroto JP, Mellado B, Melichar B, Tomasek J, Kremer A, Kim HJ, Wood K, Dutcus C, Larkin J. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol. 2015 Nov;16(15):1473-1482. doi: 10.1016/S1470-2045(15)00290-9. Epub 2015 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Select Inclusion Criteria:\n\n* Histologically confirmed diagnosis of renal cell carcinoma.\n* Phase 2: Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable).\n* Documented evidence of unresectable advanced or metastatic RCC. Phase 2: Radiographic evidence of disease progression according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Phase 2: One prior vascular endothelial growth factor (VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib, pazopanib, bevacizumab, axitinib, vatalanib, AV951/tivozanib) for unresectable advanced or metastatic RCC.\n* Phase 2: Measurable disease meeting the following criteria: a.) at least 1 lesion of greater than or equal to 1.5 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 cm in the short axis diameter for a lymph node which is serially measurable according to Modified RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI) or photography. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.\n\nSelect Exclusion Criteria:\n\nPhase 1b or Phase 2 specific per below:\n\n* Phase 1b only: Subjects with untreated or unstable metastasis to the central nervous system (CNS) are excluded. Subjects who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and in whom stability has been proven by at least 2 CT or MRI scans obtained at least 4 weeks apart are eligible for Phase 1b only. Phase 2 only: Subjects with CNS (e.g., brain or leptomeningeal) metastasis are excluded.\n* Phase 2 only: More than one prior VEGF-targeted treatment for unresectable advanced or metastatic RCC.\n\nPhase 1b or Phase 2 specific per below:\n\n* Phase 1b only: Prior exposure to lenvatinib. Phase 2 only: Prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor.\n* Subjects should not have received any anticancer treatment within 21 days or any investigational agent within 30 days prior to the first dose of study drug and should have recovered from any toxicity related to previous anticancer treatment. Major surgery within 3 weeks prior to the first dose of study drug.\n* Subjects having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n* Subjects with urine protein greater than or equal to 1 g/24 hours will be ineligible. Uncontrolled diabetes as defined by fasting serum glucose at 1.5 x ULN.\n* Phase 2 only: Active malignancy (except for renal cell carcinoma, melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.\n* Known intolerance to any of the study drugs (or any of the excipients) and/or known hypersensitivity to rapamycins (e.g., sirolimus, everolimus, temsirolimus) or any of the excipients.\n* Phase 1b only: Subjects who discontinued prior tyrosine kinase inhibitor due to toxicity will be ineligible.'}, 'identificationModule': {'nctId': 'NCT01136733', 'briefTitle': 'A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase 1b/2 Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment', 'orgStudyIdInfo': {'id': 'E7080-G000-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenvatinib', 'interventionNames': ['Drug: Lenvatinib']}, {'type': 'EXPERIMENTAL', 'label': 'Lenvatinib plus Everolimus', 'interventionNames': ['Drug: Lenvatinib', 'Drug: Everolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Everolimus', 'interventionNames': ['Drug: Everolimus']}], 'interventions': [{'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['E7080, Lenvima, Kisplyx'], 'description': 'taken orally, once a day', 'armGroupLabels': ['Lenvatinib', 'Lenvatinib plus Everolimus']}, {'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Afinitor'], 'description': 'taken orally, once a day', 'armGroupLabels': ['Everolimus', 'Lenvatinib plus Everolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Olomouc', 'country': 'Czechia', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pamplona', 'country': 'Spain', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'city': 'Bristol', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Guildford', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'Ipswich', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'city': 'Leicester', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'city': 'Southampton', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Surrey', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Eisai Medical Services', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}