Viewing Study NCT01119456

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Ignite Creation Date: 2025-12-24 @ 11:31 PM
Ignite Modification Date: 2025-12-25 @ 9:19 PM
Study NCT ID: NCT01119456
Status: COMPLETED
Last Update Posted: 2019-02-15
First Post: 2010-05-06
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study of IMC-RON8 in Advanced 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'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'otherDetails': 'Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 13, 'otherNumAffected': 11, 'seriousNumAtRisk': 13, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 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'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of IMC-RON8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8', 'description': 'IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.\n\nParticipants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Because only 1 DLT was observed in the study, data were insufficient to determine the MTD.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through end of study treatment (up to 48 weeks)', 'description': 'The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \\>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).', 'unitOfMeasure': 'mg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'title': 'First infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '111', 'spread': '31', 'groupId': 'OG000'}, {'value': '183', 'spread': '24', 'groupId': 'OG001'}, {'value': '369', 'spread': '20', 'groupId': 'OG002'}, {'value': '437', 'spread': '20', 'groupId': 'OG003'}, {'value': '379', 'spread': '17', 'groupId': 'OG004'}, {'value': '506', 'spread': '39', 'groupId': 'OG005'}, {'value': '581', 'spread': '7', 'groupId': 'OG006'}, {'value': '706', 'spread': '24', 'groupId': 'OG007'}]}]}, {'title': 'Multiple infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '139', 'spread': '50', 'groupId': 'OG000'}, {'value': '263', 'spread': '17', 'groupId': 'OG001'}, {'value': '452', 'spread': '29', 'groupId': 'OG002'}, {'value': '518', 'spread': '25', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': '\\<3 participants. The participants individual value is 560.97.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': '\\<3 participants. The participants individual values were 1055.57 and 711.99.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose', 'description': 'The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax.', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for Cmax. No participant was analyzed for the geometric mean (%CV) of Cmax after multiple infusions in the 15, 20, 30, and 40 q2w treatment arms.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Curve (AUC) of IMC-RON8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'title': 'AUC(0-tlast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8320', 'spread': '63', 'groupId': 'OG000'}, {'value': '12500', 'spread': '14', 'groupId': 'OG001'}, {'value': '23800', 'spread': '37', 'groupId': 'OG002'}, {'value': '29000', 'spread': '30', 'groupId': 'OG003'}, {'value': '35600', 'spread': '22', 'groupId': 'OG004'}, {'value': '40500', 'spread': '87', 'groupId': 'OG005'}, {'value': '56900', 'spread': '34', 'groupId': 'OG006'}, {'value': '70200', 'spread': '25', 'groupId': 'OG007'}]}]}, {'title': 'AUC tau', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '10400', 'spread': '87', 'groupId': 'OG000'}, {'value': '19400', 'spread': '11', 'groupId': 'OG001'}, {'value': '31500', 'spread': '51', 'groupId': 'OG002'}, {'value': '29900', 'spread': '47', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'n \\<3 participants. The participants individual value was 560.97.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'n \\<3 participants. The participants individual values were 113000 and 72200.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose', 'description': 'The AUC from time 0 to the last quantifiable concentration \\[AUC(0-tlast)\\] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau.', 'unitOfMeasure': 'micrograms*hour/milliliter (mcg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for AUC(0-tlast) or AUC tau. No participant was analyzed for the geometric mean (%CV) of AUC tau in the 15, 20, 30, and 40 q2w treatment arms.'}, {'type': 'SECONDARY', 'title': 'Immunogenicity of IMC-RON8', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'timeFrame': 'Prior to first infusion through study completion (up to 52 weeks)', 'description': 'An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Immunogenicity data were not collected.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG004', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '125'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}, {'value': '60', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '120'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '50', 'upperLimit': '140'}, {'value': '133', 'groupId': 'OG004', 'lowerLimit': '40', 'upperLimit': '160'}, {'value': '40', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '120'}, {'value': '40', 'groupId': 'OG006', 'lowerLimit': '20', 'upperLimit': '94'}, {'value': '120', 'groupId': 'OG007', 'lowerLimit': '0', 'upperLimit': '200'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks)', 'description': 'The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug and had tumor tissue samples.'}, {'type': 'SECONDARY', 'title': 'Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met'}, {'id': 'OG004', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'title': 'SD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to measured PD (up to 48 weeks)', 'description': 'Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'OG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'classes': [{'title': 'Death Due to PD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Death, Cause Unknown', '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': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through study completion (up to 52 weeks)', 'description': 'The number of participants who died is reported by cause of death.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'FG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'FG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'FG003', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met'}, {'id': 'FG004', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met'}, {'id': 'FG005', 'title': 'IMC-RON8 (20 mg/kg q2w)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'FG006', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'FG007', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In this dose escalation study, a completed participant was either a participant who completed the initial 4-week treatment cycle (and 2-weeks of observation for specified treatment arms) or one who discontinued therapy, during the same time period, for a narnatumab (IMC-RON8)-related toxicity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'IMC-RON8 (5 mg/kg qw)', 'description': 'IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG001', 'title': 'IMC-RON8 (10 mg/kg qw)', 'description': 'IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG002', 'title': 'IMC-RON8 (15 mg/kg qw)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nThe initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG003', 'title': 'IMC-RON8 (15 mg/kg q2w)', 'description': 'IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG004', 'title': 'IMC-RON8 (20 mg/kg q2w', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG005', 'title': 'IMC-RON8 (30 mg/kg q2w)', 'description': 'IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG006', 'title': 'IMC-RON8 (40 mg/kg q2w)', 'description': 'IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.\n\nFollowing the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG007', 'title': 'IMC-RON8 (20 mg/kg qw)', 'description': 'IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.\n\nParticipants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '17.2', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '70.5', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '57.7', 'spread': '9.1', 'groupId': 'BG004'}, {'value': '38.0', 'spread': '13.1', 'groupId': 'BG005'}, {'value': '67.3', 'spread': '6.0', 'groupId': 'BG006'}, {'value': '58.7', 'spread': '11.6', 'groupId': 'BG007'}, {'value': '59.2', 'spread': '13.5', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'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': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}]}]}, {'title': 'Other', 'categories': [{'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': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2010-05-06', 'resultsFirstSubmitDate': '2017-09-27', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Died', 'timeFrame': 'Baseline through study completion (up to 52 weeks)', 'description': 'The number of participants who died is reported by cause of death.'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of IMC-RON8', 'timeFrame': 'Baseline through end of study treatment (up to 48 weeks)', 'description': 'The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \\>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8', 'timeFrame': 'First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose', 'description': 'The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax.'}, {'measure': 'PK: Area Under the Curve (AUC) of IMC-RON8', 'timeFrame': 'First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose', 'description': 'The AUC from time 0 to the last quantifiable concentration \\[AUC(0-tlast)\\] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau.'}, {'measure': 'Immunogenicity of IMC-RON8', 'timeFrame': 'Prior to first infusion through study completion (up to 52 weeks)', 'description': 'An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study.'}, {'measure': 'Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8)', 'timeFrame': 'Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks)', 'description': 'The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group.'}, {'measure': 'Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)', 'timeFrame': 'Baseline to measured PD (up to 48 weeks)', 'description': 'Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to \\<10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tumors', 'Macrophage stimulating 1 receptor, human', 'RON protein', 'RON receptor protein tyrosine kinase'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has histologically-confirmed advanced primary or recurrent solid tumors that have not responded to standard therapy or for which no standard therapy is available\n* The participant has measurable or non-measurable disease\n* The participant has not received major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy within 28 days prior to the first dose of study therapy\n* The participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2\n* The participant has adequate hematologic function\n* The participant has adequate renal function as defined by serum creatinine ≤1.5 times the institutional upper limit of normal (ULN)\n* The participant has a life expectancy \\>3 months\n\nExclusion Criteria:\n\n* The participant has received chemotherapy or therapeutic radiation therapy within 28 days prior to the first dose of study therapy\n* The participant has ongoing toxicities of \\>Grade 1 associated with any prior treatment\n* The participant has a known sensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-RON8\n* The participant has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy\n* The participant has received treatment with agents specifically targeting the RON ligand or receptor within 6 weeks prior to first dose of study therapy\n* The participant has undergone a major surgical procedure, open biopsy, or experienced a significant traumatic injury within 28 days prior to the first dose of study therapy\n* The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding, or any other serious uncontrolled medical disorders in the opinion of the investigator\n* The participant has known or suspected brain or leptomeningeal metastases (participants with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and may not be taking steroids; participants receiving anticonvulsants are eligible)\n* The participant has a serious or nonhealing active wound, ulcer, or bone fracture\n* The participant is currently using or has received a thrombolytic agent within 28 days prior to first dose of study therapy\n* The participant is receiving full-dose warfarin (participants receiving low-dose warfarin to maintain the patency of permanent, indwelling intravenous catheters are eligible if the international normalized ratio is \\<1.5)\n* The participant is receiving intravenous heparin'}, 'identificationModule': {'nctId': 'NCT01119456', 'briefTitle': 'A Study of IMC-RON8 in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase 1 Study of the Anti-Ron Receptor Monoclonal Antibody IMC-RON8 in Patients With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or for Whom No Standard Therapy is Available', 'orgStudyIdInfo': {'id': '13958'}, 'secondaryIdInfos': [{'id': 'CP21-0901', 'type': 'OTHER', 'domain': 'ImClone Systems'}, {'id': 'I5D-IE-JRCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-RON8', 'description': 'A monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8).', 'interventionNames': ['Biological: IMC-RON8']}], 'interventions': [{'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '5 milligrams per kilogram (mg/kg) intravenously (IV)\n\nOnce a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.\n\nCohort 1', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '10 mg/kg IV\n\nOnce a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.\n\nCohort 2', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '15 mg/kg IV\n\nOnce a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.\n\nCohort 3', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '15 mg/kg IV\n\nOnce every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.\n\nCohort 4', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '20 mg/kg IV\n\nOnce every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.\n\nCohort 5', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '25 or 30 mg/kg IV\n\nOnce every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.\n\nCohort 6', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '30, 35, or 40 mg/kg IV\n\nOnce every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.\n\nCohort 7', 'armGroupLabels': ['IMC-RON8']}, {'name': 'IMC-RON8', 'type': 'BIOLOGICAL', 'otherNames': ['Narnatumab', 'LY3012219'], 'description': '20 or 25 mg/kg IV\n\nOnce every week for each 4-week treatment cycle, for a total of four doses per cycle.\n\nCohort 8', 'armGroupLabels': ['IMC-RON8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', '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': 39.76838, 'lon': -86.15804}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', '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': 42.33143, 'lon': -83.04575}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', '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': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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'}}}}