Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT01115803
Status:
TERMINATED
Last Update Posted:
2019-02-05
First Post:
2010-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'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'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C588151', 'term': 'LY2584702'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study terminated early. Dose confirmation, Part B, was not initiated.'}}, 'adverseEventsModule': {'description': 'Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recommended Dose for Phase 2 Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2584702 + Erlotinib', 'description': 'Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.'}, {'id': 'OG001', 'title': 'LY2584702+Everolimus', 'description': 'Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The Phase 2 dose of LY2584702 in combination with erlotinib was not determined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'The Phase 2 dose of LY2584702 in combination with everolimus was not determined.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 cycles of 28 days', 'description': 'The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.', 'unitOfMeasure': 'milligrams (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Effects (Number of Participants With Adverse Events)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Non-SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 7 months', 'description': 'Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': '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': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'timeFrame': 'Baseline to disease progression or death or up to 166 days postbaseline', 'description': 'PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants were analyzed as no data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 (BID) + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0', 'comment': 'No participants achieved PR or CR; confidence interval could not be determined.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to disease progression or death or up to 6 cycles of 28 days', 'description': 'Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and assessed for RR.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'title': 'C1 D1, single dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '918.24', 'spread': '42.9', 'groupId': 'OG000'}, {'value': '999.54', 'spread': '68.3', 'groupId': 'OG001'}, {'value': '2421.64', 'spread': '35.1', 'groupId': 'OG002'}, {'value': '1768.59', 'spread': '50.3', 'groupId': 'OG003'}, {'value': '1192.46', 'spread': '31.5', 'groupId': 'OG004'}, {'value': '2286.22', 'spread': '7.3', 'groupId': 'OG005'}, {'value': '1569.24', 'spread': '28.6', 'groupId': 'OG006'}]}]}, {'title': 'C1 D8, steady state', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1125.46', 'spread': '64.6', 'groupId': 'OG000'}, {'value': '1636.71', 'spread': '52.6', 'groupId': 'OG001'}, {'value': '2709.61', 'spread': '50.7', 'groupId': 'OG002'}, {'value': '1967.04', 'spread': '24.8', 'groupId': 'OG003'}, {'value': '1169.95', 'spread': '25.2', 'groupId': 'OG004'}, {'value': '2260.71', 'spread': '34.8', 'groupId': 'OG005'}, {'value': '2109.62', 'spread': '44.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had Cmax values.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics, Area Under the Concentration Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'title': 'AUC0-8, D1, single dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4436.60', 'spread': '50.6', 'groupId': 'OG000'}, {'value': '4308.98', 'spread': '79.8', 'groupId': 'OG001'}, {'value': '8610.54', 'spread': '49.4', 'groupId': 'OG002'}, {'value': '8091.93', 'spread': '47.8', 'groupId': 'OG003'}, {'value': '5699.856', 'spread': '31.9', 'groupId': 'OG004'}, {'value': '11410.18', 'spread': '3.9', 'groupId': 'OG005'}, {'value': '6097.44', 'spread': '15.9', 'groupId': 'OG006'}]}]}, {'title': 'AUC0-8, D8, steady state', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5395.96', 'spread': '70.7', 'groupId': 'OG000'}, {'value': '7948.43', 'spread': '50.4', 'groupId': 'OG001'}, {'value': '15225.08', 'spread': '43.0', 'groupId': 'OG002'}, {'value': '13959.74', 'spread': '45.6', 'groupId': 'OG003'}, {'value': '5460.80', 'spread': '23.3', 'groupId': 'OG004'}, {'value': '11327.33', 'spread': '34.7', 'groupId': 'OG005'}, {'value': '10527.68', 'spread': '44.1', 'groupId': 'OG006'}]}]}, {'title': 'AUC0-∞, D1, single dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '8699.54', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '7627.50', 'spread': '37.9', 'groupId': 'OG001'}, {'value': '20813.83', 'spread': '25.0', 'groupId': 'OG002'}, {'value': '16254.07', 'spread': '20.3', 'groupId': 'OG003'}, {'value': '11386.03', 'spread': '34.8', 'groupId': 'OG004'}, {'value': '22343.07', 'spread': 'NA', 'comment': 'Only 2 participants analyzed', 'groupId': 'OG005'}, {'value': '8764.13', 'spread': '14.1', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle', 'description': 'AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).', 'unitOfMeasure': 'nanograms*hours per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had AUC values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 112 Days', 'description': 'BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and assessed for BOR.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.'}, {'id': 'OG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'OG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'OG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of study drug discontinuation', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'FG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'FG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'FG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'FG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'FG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'FG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'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': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'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': '1'}]}, {'type': 'Lost to Follow-up', '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': 'Progressive Disease during Cycle1', 'reasons': [{'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': '1'}]}]}], 'preAssignmentDetails': 'A 2 phase study, a dose escalation phase and a dose confirmation phase. The dose confirmation phase was not initiated. Participant flow reports those participants who discontinued from study drug. Participants who completed 1 cycle of treatment, had the required assessment or an adverse event (AE) were considered to have completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD', 'description': '50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'BG001', 'title': 'Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'BG002', 'title': 'Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'BG003', 'title': 'Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD', 'description': '75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.'}, {'id': 'BG004', 'title': 'Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'BG005', 'title': 'Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD', 'description': '100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'BG006', 'title': 'Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD', 'description': '50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '7.97', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '7.86', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '11.02', 'groupId': 'BG002'}, {'value': '63.0', 'spread': '3.39', 'groupId': 'BG003'}, {'value': '49.0', 'spread': '7.55', 'groupId': 'BG004'}, {'value': '47.7', 'spread': '16.01', 'groupId': 'BG005'}, {'value': '47.5', 'spread': '16.17', 'groupId': 'BG006'}, {'value': '54.0', 'spread': '11.65', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Primary objective has been met; safety and pharmacokinetics have been characterized.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2010-04-22', 'resultsFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-01', 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation', 'timeFrame': 'Within 30 days of study drug discontinuation'}], 'primaryOutcomes': [{'measure': 'Recommended Dose for Phase 2 Studies', 'timeFrame': 'Baseline up to 6 cycles of 28 days', 'description': 'The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.'}], 'secondaryOutcomes': [{'measure': 'Clinically Significant Effects (Number of Participants With Adverse Events)', 'timeFrame': 'Baseline up to 7 months', 'description': 'Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline to disease progression or death or up to 166 days postbaseline', 'description': 'PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.'}, {'measure': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]', 'timeFrame': 'Baseline to disease progression or death or up to 6 cycles of 28 days', 'description': 'Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.'}, {'measure': 'Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702', 'timeFrame': 'Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle'}, {'measure': 'Pharmacokinetics, Area Under the Concentration Time Curve (AUC)', 'timeFrame': 'Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle', 'description': 'AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).'}, {'measure': 'Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]', 'timeFrame': 'Baseline up to 112 Days', 'description': 'BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Cancer', 'Metastatic Cancer', 'Non-Small Cell Lung Cancer', 'Renal Cell Carcinoma', 'Neuroendocrine Tumors'], 'conditions': ['Metastases, Neoplasm', 'Carcinoma, Non-small Cell Lung', 'Renal Cell Carcinoma', 'Neuroendocrine Tumors']}, 'referencesModule': {'references': [{'pmid': '24456794', 'type': 'DERIVED', 'citation': 'Hollebecque A, Houede N, Cohen EE, Massard C, Italiano A, Westwood P, Bumgardner W, Miller J, Brail LH, Benhadji KA, Soria JC. A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Eur J Cancer. 2014 Mar;50(5):876-84. doi: 10.1016/j.ejca.2013.12.006. Epub 2014 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.', 'detailedDescription': 'Study JGCB will consist of the following parts:\n\nPart 1 - Dose Escalation to maximum tolerated dose in each arm.\n\nArm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer.\n\nArm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer.\n\nPart 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.\n\nArm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung cancer.\n\nArm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Dose Escalation portion (Part 1): have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease (including Non-Hodgkin's Lymphoma) for which no proven effective therapy exists.\n* Dose Confirmation portion (Part 2): have histological or cytological evidence of:\n\n 1. Arm A: advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.\n 2. Arm B: advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib, or advanced neuroendocrine tumors.\n* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.\n\n 1. Dose Escalation portion (Part 1): participants may have measurable or nonmeasurable disease.\n 2. Dose Confirmation portion (Part 2): participants must have measurable disease.\n* Have adequate organ function including:\n\n 1. Hematologic: absolute neutrophil count (ANC) greater than or equal to 1.5 x 10⁹/liters (L), platelets greater than or equal to 100 x 10⁹/L, and hemoglobin greater than or equal to 8 grams/deciliter (g/dL).\n 2. Hepatic: bilirubin less than or equal to 1.5 times upper limits of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable. Participants with bone metastases may enter with alkaline phosphatase values less than or equal to 5 times ULN, as long as other hepatic parameters meet inclusion criteria.\n 3. Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance \\>45 milliliter/minute (ml/mn).\n* Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 2 weeks (3 weeks for myelosuppressive agents) prior to study enrollment, and have recovered from the acute effects of therapy. At the discretion of the investigator, participants with prostate cancers progressing under luteinizing hormone-releasing hormone (LHRH) agonists therapy, and participants with adrenal carcinomas using mitotane, may have that treatment continued while receiving study drug.\n\nExclusion Criteria:\n\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.\n* Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.\n* Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated CNS metastases are eligible provided their disease is radiographically stable and asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastasis is not required.\n* Concomitant treatment by strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4 inducers.\n* Have an acute or chronic leukemia.\n* Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug. In addition, recipients of an allogeneic stem-cell transplant must have discontinued immunosuppressive therapy at least 24 hours before study drug administration with no more than Grade 1 acute graft-versus-host disease.\n* For Dose Confirmation portion (Part 2): have previously received erlotinib for Arm A or everolimus for Arm B."}, 'identificationModule': {'nctId': 'NCT01115803', 'briefTitle': 'A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '12531'}, 'secondaryIdInfos': [{'id': 'I3G-MC-JGCB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: LY2584702 + Erlotinib', 'description': 'Participants received 50 mg LY2584702 once daily (QD )+ 150 mg Erlotinib QD, 50 mg LY2584702 twice daily (BID) + 150 mg Erlotinib QD, 100 mg LY2584702 BID + 150 mg Erlotinib QD and 75 mg LY2584702 BID + 150 mg Erlotinib QD.', 'interventionNames': ['Drug: LY2584702', 'Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: LY2584702 + Everolimus', 'description': 'Participants received 50 mg LY2584702 QD + 10 mg Everolimus QD, 100 mg LY2584702 QD + 10 mg Everolimus QD and 50 mg LY2584702 BID + 10 mg Everolimus QD.', 'interventionNames': ['Drug: LY2584702', 'Drug: Everolimus']}], 'interventions': [{'name': 'LY2584702', 'type': 'DRUG', 'description': 'Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.', 'armGroupLabels': ['Arm A: LY2584702 + Erlotinib', 'Arm B: LY2584702 + Everolimus']}, {'name': 'Erlotinib', 'type': 'DRUG', 'description': 'Supplied as 25 mg, 100 mg, or 150 mg tablets, administered orally, daily for two 28-day cycles.\n\nStarting dose is 150mg. Doses may be decreased in 50mg increments if necessary due to toxicity.', 'armGroupLabels': ['Arm A: LY2584702 + Erlotinib']}, {'name': 'Everolimus', 'type': 'DRUG', 'description': 'Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.', 'armGroupLabels': ['Arm B: LY2584702 + Everolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}