Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT01380769
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2011-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542292', 'term': 'IT-101'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'asenderowicz@ceruleanrx.com', 'phone': '617 551 9600', 'title': 'Adrian Senderowicz', 'organization': 'Cerulean Pharma Inc.'}, 'certainAgreement': {'otherDetails': "The Investigator interested in participating in writing the manuscript should contact the Sponsor. The Investigsator shall not make any Study-related publication or other disclosure without the Sponsor's prior written approval, which may be withheld or granted by the Sponsor, in its sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose to 30 days after the last dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'CRLX101+BSC', 'description': '15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.', 'otherNumAtRisk': 97, 'otherNumAffected': 76, 'seriousNumAtRisk': 97, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Best Supportive Care (BSC) Only', 'description': 'Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.', 'otherNumAtRisk': 50, 'otherNumAffected': 39, 'seriousNumAtRisk': 50, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 46, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 18, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'Eastern Cooperative Oncology Group performance status worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'decreased appetitie', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'non-small cell lung cancer', 'notes': 'progression of disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}], 'seriousEvents': [{'term': 'atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'anaphylatic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'liver function test', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'esophagobronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}, {'term': 'superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, version 16.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CRLX101', 'description': 'CRLX101: CRLX101 is administered at 15mg/m2 IV every other week'}, {'id': 'OG001', 'title': 'Best Supportive Care', 'description': 'Best Supportive Care: best supportive care'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.70', 'upperLimit': '8.68'}, {'value': '11.9', 'comment': 'Insufficient data to estimate', 'groupId': 'OG001', 'lowerLimit': '6.74', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 18 months', 'description': 'Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit. (Confidence interval if insufficient data to estimate NE = 99999.99)'}, {'type': 'SECONDARY', 'title': 'Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CRLX101', 'description': 'CRLX101: CRLX101 is administered at 15mg/m2 IV every other week'}, {'id': 'OG001', 'title': 'Best Supportive Care', 'description': 'Best Supportive Care: best supportive care'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CRLX101 + BSC (Best Supportive Care)', 'description': '15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.'}, {'id': 'FG001', 'title': 'BSC (Best Supportive Care) Alone', 'description': 'Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'subjects in ITT with reported date of death, alive with progression, or alive without progression', 'groupId': 'FG000', 'numSubjects': '91'}, {'comment': 'subjects in ITT with reported date of death, alive with progression, or alive without progression', 'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted from 04 Jul 2011 to 07 Oct 2014. A total of 24 medical clinics participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CRLX101 + BSC (Best Supportive Care)', 'description': '15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.'}, {'id': 'BG001', 'title': 'BSC (Best Supportive Care) Alone', 'description': 'Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \\[G-CSF\\]) as required.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '8.22', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '6.42', 'groupId': 'BG001'}, {'value': '59.4', 'spread': '7.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-18', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only', 'timeFrame': 'Up to 18 months', 'description': 'Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.'}], 'secondaryOutcomes': [{'measure': 'Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only', 'timeFrame': '12 months', 'description': 'Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).', 'detailedDescription': 'Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients who are ≥ 18-years of age.\n* Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.\n* Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.\n* ECOG performance status of 0 or 1.\n* Life expectancy of at least 3 months.\n* Hemoglobin ≥ 10 g/dL.\n* Absolute neutrophil count (ANC) ≥ 1500 cells/µL without growth factor support.\n* Platelet count ≥ 100,000 cells/µL without support.\n* Adequate hepatic and renal function including the following: Total bilirubin \\< 2 × ULN, AST or ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastasis, PTT within normal limits, INR ≤ 1.5, Serum Creatinine \\<1.5 ULN\n* At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post nitrosoureas therapy.\n* Full recovery from diagnostic or therapeutic surgery (i.e., complete wound healing) and at least 30 days have elapsed prior to initial dosing.\n* Full recovery from the toxic effects of prior therapy (i.e., Common Toxicity Criteria \\[CTC\\] Grade 1 or less with the exception of Grade 2 alopecia).\n* Women of childbearing potential must have adequate pregnancy test. If postmenopausal, must be ≥ 12 months since last menses.\n* Women of childbearing potential and men must agree to use an effective form of contraception during the study and for 60 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.\n* Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.\n* More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.\n* History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.\n* History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.\n* Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure\n* History of cardiac arrhythmia requiring medical or electrical therapy.\n* QTc \\> 450 msec for males and \\> 470 msec for females.\n* Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.\n* History of organ or bone marrow transplant.\n* Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.\n* Any investigational therapy within 28 days of study entry.\n* Pregnant or nursing.\n* Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live \\< 90 days\n* Severe or significant allergy to any chemotherapy or premedication.\n* Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.\n* Any prior cancer treatment with a topoisomerase I inhibitor.'}, 'identificationModule': {'nctId': 'NCT01380769', 'briefTitle': 'A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Pharma'}, 'officialTitle': 'A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy', 'orgStudyIdInfo': {'id': 'CRLX-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRLX101', 'interventionNames': ['Drug: CRLX101']}, {'type': 'OTHER', 'label': 'Best supportive care', 'interventionNames': ['Other: Best Supportive Care']}], 'interventions': [{'name': 'CRLX101', 'type': 'DRUG', 'otherNames': ['NLG207'], 'description': 'CRLX101 is administered at 15mg/m2 IV every other week', 'armGroupLabels': ['CRLX101']}, {'name': 'Best Supportive Care', 'type': 'OTHER', 'description': 'best supportive care', 'armGroupLabels': ['Best supportive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430032', 'city': 'Saransk', 'state': 'Respublika Mordoviya', 'country': 'Russia', 'facility': 'State Medical Institution Republican Oncology Center', 'geoPoint': {'lat': 54.18485, 'lon': 45.17166}}, {'zip': '420029', 'city': "Kazan'", 'state': 'Tatarstan Republic', 'country': 'Russia', 'facility': 'State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk Regional Clinical Oncology Center', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '241033', 'city': 'Bryansk', 'country': 'Russia', 'facility': 'State Healthcare Institution: Bryansk Regional Oncology Center', 'geoPoint': {'lat': 53.27096, 'lon': 34.32143}}, {'zip': '454087', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Chelyabinsk Regional Clinical Oncology Center', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '305035', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Kursk Regional Oncology Center', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Non-Government Medical Institution: Central Clinical Hospital #2', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603081', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630047', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'City Clinical Hospital #1', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '357500', 'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'State Medical Institution: Pyatigorsk Oncological Center', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City Clinical Oncology Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '355047', 'city': 'Stavropol', 'country': 'Russia', 'facility': 'Stavropol Regional Clinical Oncology Center', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}, {'zip': '392013', 'city': 'Tambov', 'country': 'Russia', 'facility': 'Tambov Regional Oncology Center', 'geoPoint': {'lat': 52.73632, 'lon': 41.44102}}, {'zip': '690105', 'city': 'Vladivostok', 'country': 'Russia', 'facility': 'Primorsky Regional Oncology Center', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}, {'zip': '150054', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Regional Clinical Oncology Center', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '49102', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Dnipropetrovsk State Medical Academy', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83092', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '76000', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61070', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '29009', 'city': 'Khmelnytsky', 'country': 'Ukraine', 'facility': 'Khmelnytskyi Regional Oncology Center'}, {'zip': '03115', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyiv City Oncology Hospital', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '40005', 'city': 'Sumy', 'country': 'Ukraine', 'facility': 'Sumy Regional Clinical Oncology Center', 'geoPoint': {'lat': 50.91741, 'lon': 34.79906}}, {'zip': '88011', 'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Zakarpattia Regional Clinical Oncology Center', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}], 'overallOfficials': [{'name': 'NewLink Genetics', 'role': 'STUDY_CHAIR', 'affiliation': 'NewLink Genetics Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewLink Genetics Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}