Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2026-03-17 @ 1:25 AM
Study NCT ID:
NCT00560235
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C525021', 'term': 'figitumumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Figitumumab 30 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).', 'otherNumAtRisk': 21, 'otherNumAffected': 19, 'seriousNumAtRisk': 21, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 7}, {'id': 'EG006', 'title': 'Figitumumab 30mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.', 'otherNumAtRisk': 107, 'otherNumAffected': 99, 'seriousNumAtRisk': 107, 'seriousNumAffected': 47}, {'id': 'EG007', 'title': 'Figitumumab 30 mg/kg + Rapamycin (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 13}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eye movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 20}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 16}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 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'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '22.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and every cycle (4 weeks), for up to 6 cycles', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off."}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every cycle (4 weeks), until progression or death', 'description': 'PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with ESFT and who started treatment with figitumumab.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '10.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment', 'description': 'Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with ESFT and who started treatment with figitumumab.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG001', 'title': 'Figitumumab 30 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}], 'classes': [{'title': 'Cycle 1 (n=4, 6, 21)', 'categories': [{'measurements': [{'value': '513.2', 'spread': '42', 'groupId': 'OG000', 'lowerLimit': '42'}, {'value': '1075', 'spread': '21', 'groupId': 'OG001', 'lowerLimit': '21'}, {'value': '975.6', 'spread': '26', 'groupId': 'OG002', 'lowerLimit': '26'}]}]}, {'title': 'Cycle 5 (n=2, 2, 8)', 'categories': [{'measurements': [{'value': '729.0', 'spread': '47', 'groupId': 'OG000', 'lowerLimit': '47'}, {'value': '1133', 'spread': '9', 'groupId': 'OG001', 'lowerLimit': '9'}, {'value': '1043', 'spread': '47', 'groupId': 'OG002', 'lowerLimit': '47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1', 'unitOfMeasure': 'milligrams per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Trough Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG001', 'title': 'Figitumumab 30 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}], 'classes': [{'categories': [{'measurements': [{'value': '389.0', 'groupId': 'OG000'}, {'value': '345.0', 'groupId': 'OG001'}, {'value': '283.6', 'spread': '53', 'groupId': 'OG002', 'lowerLimit': '53'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 6: predose on Day 1', 'description': 'Cmin is the concentration at the end of treatment cycle (next cycle predose).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration at End of Infusion (Cendinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG001', 'title': 'Figitumumab 30 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}, {'id': 'OG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}], 'classes': [{'title': 'Cycle 1 (n=4, 6, 21)', 'categories': [{'measurements': [{'value': '513.2', 'spread': '42', 'groupId': 'OG000', 'lowerLimit': '42'}, {'value': '1075', 'spread': '21', 'groupId': 'OG001', 'lowerLimit': '21'}, {'value': '975.6', 'spread': '26', 'groupId': 'OG002', 'lowerLimit': '26'}]}]}, {'title': 'Cycle 5 (n=2, 2, 8)', 'categories': [{'measurements': [{'value': '729.0', 'spread': '47', 'groupId': 'OG000', 'lowerLimit': '47'}, {'value': '1133', 'spread': '9', 'groupId': 'OG001', 'lowerLimit': '9'}, {'value': '1043', 'spread': '47', 'groupId': 'OG002', 'lowerLimit': '47'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 2 and Cycle 5 Day 1', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).'}, {'id': 'OG001', 'title': 'Figitumumab 30 mg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).'}, {'id': 'OG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).'}], 'classes': [{'categories': [{'measurements': [{'value': '423000', 'groupId': 'OG000'}, {'value': '475000', 'groupId': 'OG001'}, {'value': '302900', 'spread': '46', 'groupId': 'OG002', 'lowerLimit': '46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 5: 1 hour post-infusion on Day 1', 'description': 'The dosing interval was 1 cycle (4 weeks) in this study.', 'unitOfMeasure': 'milligram*hour per liter (mg*hr/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 20 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).'}, {'id': 'OG001', 'title': 'Figitumumab 30 mg/kg Dose Escalation (Phase 1)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).'}, {'id': 'OG002', 'title': 'Figitumumab 30 mg/kg Dose Extension (Phase 1B)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).'}], 'classes': [{'title': 'Cycle 1 (n=3, 5, 16)', 'categories': [{'measurements': [{'value': '187200', 'spread': '37', 'groupId': 'OG000', 'lowerLimit': '37'}, {'value': '338800', 'spread': '16', 'groupId': 'OG001', 'lowerLimit': '16'}, {'value': '343000', 'spread': '25', 'groupId': 'OG002', 'lowerLimit': '25'}]}]}, {'title': 'Cycle 5 (n=1, 1, 6)', 'categories': [{'measurements': [{'value': '423000', 'spread': 'NA', 'comment': 'Geometric CV(%) not calculated as only 1 participant was evaluated.', 'groupId': 'OG000', 'lowerLimit': 'NA'}, {'value': '509000', 'spread': 'NA', 'comment': 'Geometric CV(%) not calculated as only 1 participant was evaluated.', 'groupId': 'OG001', 'lowerLimit': 'NA'}, {'value': '310800', 'spread': '46', 'groupId': 'OG002', 'lowerLimit': '46'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1', 'description': 'AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibody (ADA) Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)', 'description': 'Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \\<6.64 corresponded to negative ADA category value.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of \\<6.64.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Figitumumab Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}, {'id': 'FG001', 'title': 'Figitumumab Dose Extension (Phase 1B)', 'description': 'Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}, {'id': 'FG002', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Phase 1B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'Ongoing at Date of Cut-Off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited separately for Phase 1 and Phase 2. A total of 138 participants were assigned to received study treatment (31 participants for Phase 1 and 107 participants for Phase 2).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Figitumumab Dose Escalation (Phase 1)', 'description': 'Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}, {'id': 'BG001', 'title': 'Figitumumab Dose Extension (Phase 1B)', 'description': 'Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}, {'id': 'BG002', 'title': 'Figitumumab 30 mg/kg (Phase 2)', 'description': 'Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '10 to <13 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': '13 to <=18 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': '18 to <30 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': '30 to <41 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': '>=41 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2011-05-18', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2007-11-15', 'dispFirstSubmitQcDate': '2011-05-18', 'resultsFirstSubmitDate': '2013-10-24', 'studyFirstSubmitQcDate': '2007-11-15', 'dispFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-14', 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Baseline and every cycle (4 weeks), for up to 6 cycles', 'description': 'Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline and every cycle (4 weeks), until progression or death', 'description': 'PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment', 'description': 'Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1'}, {'measure': 'Minimum Observed Plasma Trough Concentration (Cmin)', 'timeFrame': 'Cycle 6: predose on Day 1', 'description': 'Cmin is the concentration at the end of treatment cycle (next cycle predose).'}, {'measure': 'Plasma Concentration at End of Infusion (Cendinf)', 'timeFrame': 'Cycle 1 Day 2 and Cycle 5 Day 1'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)', 'timeFrame': 'Cycle 5: 1 hour post-infusion on Day 1', 'description': 'The dosing interval was 1 cycle (4 weeks) in this study.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1', 'description': 'AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibody (ADA) Titer', 'timeFrame': 'Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)', 'description': 'Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \\<6.64 corresponded to negative ADA category value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Ewing's Sarcoma Family of Tumors"]}, 'referencesModule': {'references': [{'pmid': '22025154', 'type': 'DERIVED', 'citation': 'Juergens H, Daw NC, Geoerger B, Ferrari S, Villarroel M, Aerts I, Whelan J, Dirksen U, Hixon ML, Yin D, Wang T, Green S, Paccagnella L, Gualberto A. Preliminary efficacy of the anti-insulin-like growth factor type 1 receptor antibody figitumumab in patients with refractory Ewing sarcoma. J Clin Oncol. 2011 Dec 1;29(34):4534-40. doi: 10.1200/JCO.2010.33.0670. Epub 2011 Oct 24.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021020', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ewing's family of tumors\n* Current disease state for which there is no curative therapy\n\nExclusion Criteria:\n\n* Prior anti-IGF-1R therapy\n* Concurrent treatment with other anti-cancer agents"}, 'identificationModule': {'nctId': 'NCT00560235', 'briefTitle': "Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed 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