Viewing Study NCT00819169

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Ignite Creation Date: 2025-12-24 @ 11:08 PM
Ignite Modification Date: 2026-01-01 @ 5:34 PM
Study NCT ID: NCT00819169
Status: TERMINATED
Last Update Posted: 2024-08-20
First Post: 2009-01-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545764', 'term': 'ganitumab'}, {'id': 'C554537', 'term': 'conatumumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bobby.Reddy@immunitybio.com', 'phone': '855-797-9277', 'title': 'Sandeep Bobby Reddy, Chief Medical Officer', 'organization': 'ImmunityBio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.', 'description': 'Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 8, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 7, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 9, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'deathsNumAffected': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 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plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from first dose up to 24 months', 'description': 'Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. 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cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)'}, {'id': 'OG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)'}, {'id': 'OG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'OG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'OG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}], 'classes': [{'title': 'AMG 655 - Binding antibody positive at any time', 'categories': [{'measurements': [{'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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'AMG 655 - Neutralizing antibody positive at any time', 'categories': [{'measurements': [{'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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'AMG 479 - Binding antibody positive at any time', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}, {'title': 'AMG 479 - Neutralizing antibody positive at any time', 'categories': [{'measurements': [{'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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from first dose up to 24 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody Population = All subjects in the full analysis set tested for antibodies during the study.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Concentration Level of AMG 655', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal 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'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '59.0'}, {'value': '313', 'groupId': 'OG002', 'lowerLimit': '261', 'upperLimit': '365'}, {'value': '244', 'groupId': 'OG003', 'lowerLimit': '240', 'upperLimit': '247'}, {'value': '266', 'groupId': 'OG004', 'lowerLimit': '266', 'upperLimit': '266'}, {'value': '240', 'groupId': 'OG005', 'lowerLimit': '115', 'upperLimit': '319'}, {'value': '224', 'groupId': 'OG006', 'lowerLimit': '130', 'upperLimit': '293'}, {'value': '327', 'groupId': 'OG007', 'lowerLimit': '275', 'upperLimit': '341'}, {'value': '247', 'groupId': 'OG008', 'lowerLimit': '91.3', 'upperLimit': '392'}]}]}, {'title': 'Cycle 3-End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 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'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Concentration Level of AMG 479', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)'}, {'id': 'OG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)'}, {'id': 'OG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'OG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'OG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}], 'classes': [{'title': 'Cycle 1-End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '272', 'groupId': 'OG000', 'lowerLimit': '198', 'upperLimit': '279'}, {'value': '268', 'groupId': 'OG001', 'lowerLimit': '268', 'upperLimit': '268'}, {'value': '303', 'groupId': 'OG002', 'lowerLimit': '257', 'upperLimit': '349'}, {'value': '215', 'groupId': 'OG003', 'lowerLimit': '193', 'upperLimit': '237'}, {'value': '297', 'groupId': 'OG004', 'lowerLimit': '297', 'upperLimit': '297'}, {'value': '227', 'groupId': 'OG005', 'lowerLimit': '130', 'upperLimit': '634'}, {'value': '236', 'groupId': 'OG006', 'lowerLimit': '121', 'upperLimit': '391'}, {'value': '324', 'groupId': 'OG007', 'lowerLimit': '248', 'upperLimit': '439'}, {'value': '254', 'groupId': 'OG008', 'lowerLimit': '169', 'upperLimit': '445'}]}]}, {'title': 'Cycle 3-End of Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '308', 'groupId': 'OG000', 'lowerLimit': '308', 'upperLimit': '308'}, {'value': '338', 'groupId': 'OG002', 'lowerLimit': '338', 'upperLimit': '338'}, {'value': '404', 'groupId': 'OG003', 'lowerLimit': '404', 'upperLimit': '404'}, {'value': '262', 'groupId': 'OG005', 'lowerLimit': '205', 'upperLimit': '364'}, {'value': '249', 'groupId': 'OG006', 'lowerLimit': '249', 'upperLimit': '249'}, {'value': '323', 'groupId': 'OG007', 'lowerLimit': '300', 'upperLimit': '381'}, {'value': '365', 'groupId': 'OG008', 'lowerLimit': '244', 'upperLimit': '420'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)', 'description': 'Median, minimum, and maximum concentration of AMG 479 at specified time points.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.'}, {'type': 'SECONDARY', 'title': 'Time to Response', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC'}, {'id': 'OG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC'}, {'id': 'OG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'OG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'OG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}], 'timeFrame': 'Time from first dose up to 24 months', 'description': 'Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'reportingStatus': 'POSTED', 'populationDescription': 'Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated.'}, {'type': 'SECONDARY', 'title': 'Duration of Response', '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'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'OG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'OG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC'}, {'id': 'OG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC'}, {'id': 'OG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'OG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'OG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}], 'timeFrame': 'Time from objective response to 24 months', 'description': 'Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors \\[RECIST\\] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Per RECIST v 1.1, disease progression is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analysis of duration of response was not calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'FG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'FG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'FG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'FG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)'}, {'id': 'FG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)'}, {'id': 'FG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'FG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'FG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '16'}, {'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '7'}]}, {'type': 'Ineligibility determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Adverse Event', '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'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Administrative Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '89', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'BG001', 'title': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'BG002', 'title': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)\n\nAMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.\n\nAMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.'}, {'id': 'BG003', 'title': 'Part 2 Cohort 1', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC'}, {'id': 'BG004', 'title': 'Part 2 Cohort 2', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC'}, {'id': 'BG005', 'title': 'Part 2 Cohort 3', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC'}, {'id': 'BG006', 'title': 'Part 2 Cohort 4', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer'}, {'id': 'BG007', 'title': 'Part 2 Cohort 5', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer'}, {'id': 'BG008', 'title': 'Part 2 Cohort 6', 'description': 'AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '20.9', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '4.4', 'groupId': 'BG002'}, {'value': '53.1', 'spread': '14.1', 'groupId': 'BG009'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '80', 'groupId': 'BG009'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '10.3', 'groupId': 'BG003'}, {'value': '67.0', 'spread': '7.3', 'groupId': 'BG004'}, {'value': '59.1', 'spread': '11.0', 'groupId': 'BG005'}, {'value': '60.2', 'spread': '8.8', 'groupId': 'BG006'}, {'value': '58.0', 'spread': '15.8', 'groupId': 'BG007'}, {'value': '51.3', 'spread': '9.8', 'groupId': 'BG008'}, {'value': '58.8', 'spread': '11.1', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Part 1 and Part 2 were analyzed separately.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '87', 'groupId': 'BG009'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '44', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '43', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For part 2 the full analysis population was used which included only those subjects that received investigational product.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '87', 'groupId': 'BG009'}]}], '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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'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': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}, {'value': '73', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'For part 2 the full analysis population was used which included only those subjects that received investigational product.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-05-25', 'size': 226055, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-18T14:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'whyStopped': 'Sponsor decision - subjects rolled over to protocol 20101116', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2015-07-13', 'completionDateStruct': {'date': '2011-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2009-01-06', 'dispFirstSubmitQcDate': '2015-07-13', 'resultsFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2009-01-06', 'dispFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-24', 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-limiting Toxicities', 'timeFrame': 'Time from first dose up to 24 months', 'description': 'Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Time from first dose up to 24 months', 'description': 'The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \\[RECIST\\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'Time from first dose up to 24 months', 'description': 'Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.'}, {'measure': 'To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation', 'timeFrame': 'Time from first dose up to 24 months'}, {'measure': 'To Evaluate the Concentration Level of AMG 655', 'timeFrame': 'Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)', 'description': 'Median, minimum, and maximum concentration of AMG 655 at specified time points.'}, {'measure': 'To Evaluate the Concentration Level of AMG 479', 'timeFrame': 'Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)', 'description': 'Median, minimum, and maximum concentration of AMG 479 at specified time points.'}, {'measure': 'Time to Response', 'timeFrame': 'Time from first dose up to 24 months', 'description': 'Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Duration of Response', 'timeFrame': 'Time from objective response to 24 months', 'description': 'Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors \\[RECIST\\] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Per RECIST v 1.1, disease progression is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.'}]}, 'conditionsModule': {'keywords': ['AMG 655', 'AMG 479', 'Apoptosis', 'Monoclonal Antibody', 'Tumor Necrosis Factor', 'Insulin-like Growth Factor'], 'conditions': ['Colorectal Cancer', 'Locally Advanced', 'Metastatic Cancer', 'Non-Small Cell Lung Cancer', 'Ovarian Cancer', 'Pancreatic Cancer', 'Sarcoma', 'Solid Tumors']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Chawla S, Tabernero, J, Kindler, H., Reckamp, K., Chiorean, E., Azad, N., Lockhard, A., Hsu, CP., Baker, N., Galimi, F., Beltran, P., Baselga, J..Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab.Targeted Oncology;Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2014 May 11. [Epub ahead of print]'}, {'pmid': '24816908', 'type': 'DERIVED', 'citation': 'Tabernero J, Chawla SP, Kindler H, Reckamp K, Chiorean EG, Azad NS, Lockhart AC, Hsu CP, Baker NF, Galimi F, Beltran P, Baselga J. Anticancer activity of the type I insulin-like growth factor receptor antagonist, ganitumab, in combination with the death receptor 5 agonist, conatumumab. Target Oncol. 2015 Mar;10(1):65-76. doi: 10.1007/s11523-014-0315-z. Epub 2014 May 11.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4317391/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be conducted in the United States and Spain.\n\nPart 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerable.\n\nPart 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC (non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and sarcoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: Histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors\n* Part 2: Histologically or cytologically confirmed, locally advanced or metastatic: NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens), Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1 prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or Sarcoma (up to 2 prior treatment regimens), according to cohort availability\n* Eastern Cooperative Group (ECOG performance status of 0 or 1\n* Women or men ≥16 years of age\n* Adequate hematology, renal, hepatic, coagulation and glycemic function.\n\nExclusion Criteria:\n\n* Presence of uncontrolled central nervous system (CNS) disease\n* Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤28 days before enrollment.\n* Prior treatment with death receptor agonists (including but not limited to rhApo2L/TRAIL \\[AMG951\\], apomab, mapatumumab, lexatumumab, CS-1008)\n* Prior treatment with IGF receptor antagonists (including but not limited to CP-751, 871, MK0646, AVE1642 or IMC-A12)'}, 'identificationModule': {'nctId': 'NCT00819169', 'briefTitle': 'QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'NantCell, Inc.'}, 'officialTitle': 'A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors', 'orgStudyIdInfo': {'id': '20070411'}, 'secondaryIdInfos': [{'id': 'QUILT-3.026', 'type': 'OTHER', 'domain': 'NantCell, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 3', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)', 'interventionNames': ['Biological: AMG 479', 'Biological: AMG 655']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)', 'interventionNames': ['Biological: AMG 479', 'Biological: AMG 655']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)', 'interventionNames': ['Biological: AMG 479', 'Biological: AMG 655']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg Q3W, or the MTD, as determined in Part 1 of the study', 'interventionNames': ['Biological: AMG 479', 'Biological: AMG 655']}], 'interventions': [{'name': 'AMG 479', 'type': 'BIOLOGICAL', 'description': 'AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.', 'armGroupLabels': ['Part 1 Cohort 1', 'Part 1 Cohort 2', 'Part 1 Cohort 3', 'Part 2']}, {'name': 'AMG 655', 'type': 'BIOLOGICAL', 'otherNames': ['AMG 655 is also known as conatumumab.'], 'description': 'AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.', 'armGroupLabels': ['Part 1 Cohort 1', 'Part 1 Cohort 2', 'Part 1 Cohort 3', 'Part 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NantCell, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}