Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01266018
Status:
TERMINATED
Last Update Posted:
2022-10-25
First Post:
2010-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C512527', 'term': 'ADI PEG20'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jskipper@lcr.org', 'phone': '12124501539', 'title': 'Jonathan Skipper PhD', 'organization': 'Ludwig Institute for Cancer Research'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to lack of efficacy and slow enrollment; therefore, only 22 of the planned 45 subjects were enrolled, treated, and evaluated for study endpoints.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs).', 'description': 'AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects (Safety Analysis Set)', 'description': 'Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Sensitive Disease', 'description': 'Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.'}, {'id': 'OG001', 'title': 'Cohort 2: Refractory Disease', 'description': 'Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \\< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.'}], 'classes': [{'title': 'Stable disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 4 to 8 weeks for up to 16 weeks', 'description': 'Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI:\n\nComplete Response (CR): Disappearance of all target lesions \\[no evidence of disease\\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all patients who were evaluable for tumor response allocation.'}, {'type': 'SECONDARY', 'title': 'Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Sensitive Disease', 'description': 'Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.'}, {'id': 'OG001', 'title': 'Cohort 2: Refractory Disease', 'description': 'Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \\< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4 TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5 TEAE (Death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Assessment of Pharmacodynamics of ADI-PEG 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects (Pharmacodynamic Analysis Set)', 'description': 'Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.'}], 'classes': [{'title': 'Arginine (Day 0)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '96'}]}]}, {'title': 'Arginine (Day 1)', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '321'}]}]}, {'title': 'Arginine (Day 8)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Arginine (Day 15)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Arginine (Day 22)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}]}]}, {'title': 'Arginine (Day 29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Arginine (Day 36)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '105'}]}]}, {'title': 'Arginine (Day 43)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '67'}]}]}, {'title': 'Arginine (Day 50)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '69'}]}]}, {'title': 'Arginine (Day 58)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '113'}]}]}, {'title': 'Citrulline (Day 0)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '40'}]}]}, {'title': 'Citrulline (Day 1)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '232'}]}]}, {'title': 'Citrulline (Day 8)', 'categories': [{'measurements': [{'value': '546', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '912'}]}]}, {'title': 'Citrulline (Day 15)', 'categories': [{'measurements': [{'value': '684', 'groupId': 'OG000', 'lowerLimit': '136', 'upperLimit': '1190'}]}]}, {'title': 'Citrulline (Day 22)', 'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '1130'}]}]}, {'title': 'Citrulline (Day 29)', 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '982'}]}]}, {'title': 'Citrulline (Day 36)', 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '367'}]}]}, {'title': 'Citrulline (Day 43)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '530'}]}]}, {'title': 'Citrulline (Day 50)', 'categories': [{'measurements': [{'value': '222', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '632'}]}]}, {'title': 'Citrulline (Day 58)', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '316'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.', 'unitOfMeasure': 'uM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.'}, {'type': 'SECONDARY', 'title': 'Assessment of Immunogenicity of ADI-PEG 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects (Pharmacodynamic Analysis Set)', 'description': 'Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.'}], 'classes': [{'title': 'Antibody titer (Day 0)', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Antibody titer (Day 1)', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Antibody titer (Day 8)', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'Antibody titer (Day 15)', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Antibody titer (Day 22)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Antibody titer (Day 29)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Antibody titer (Day 36)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Antibody titer (Day 43)', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Antibody titer (Day 50)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Antibody titer (Day 58)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.', 'unitOfMeasure': 'log 10 IU/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.'}, {'type': 'SECONDARY', 'title': 'Assessment of Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Sensitive Disease', 'description': 'Includes subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.'}, {'id': 'OG001', 'title': 'Cohort 2: Refractory Disease', 'description': 'Includes subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \\< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.'}], 'classes': [{'categories': [{'title': 'Alive at last follow-up', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Not alive at last follow-up', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 4 weeks for up to 16 months', 'description': 'Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had survival status recorded during post-study follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Sensitive Disease', 'description': 'Cohort 1 comprised subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.'}, {'id': 'FG001', 'title': 'Cohort 2: Refractory Disease', 'description': 'Cohort 2 comprised subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \\< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Defined as evaluable for the primary endpoint', 'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Subjects', 'description': 'Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Argininosuccinate Synthetase (ASS) Assay Result', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': '<5% cells positive', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'ASS tumor expression was either negative or \\< 5% positive tumor cells by immunohistochemistry', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Lack of efficacy in Cohort 2; slow enrollment in Cohort 1', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2010-12-22', 'resultsFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-10', 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Overall Response', 'timeFrame': 'Every 4 to 8 weeks for up to 16 weeks', 'description': 'Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI:\n\nComplete Response (CR): Disappearance of all target lesions \\[no evidence of disease\\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.'}], 'secondaryOutcomes': [{'measure': 'Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.'}, {'measure': 'Assessment of Pharmacodynamics of ADI-PEG 20', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.'}, {'measure': 'Assessment of Immunogenicity of ADI-PEG 20', 'timeFrame': 'Every 1 to 4 weeks for up to 16 weeks', 'description': 'Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.'}, {'measure': 'Assessment of Overall Survival', 'timeFrame': 'Every 4 weeks for up to 16 months', 'description': 'Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['small cell lung cancer', 'SCLC', 'ADI-PEG 20', 'arginine deiminase pegylated'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This was a 2-arm, open-label, phase 2 study of pegylated arginine deiminase (ADI-PEG) 20 in subjects with relapsed sensitive or refractory small cell lung cancer (SCLC). ADI-PEG 20 was administered intramuscularly (IM) at a fixed dose of 320 IU/m\\^2 once weekly for a 4-week cycle. The primary objective was to assess clinical efficacy with a primary endpoint of tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after 4 weeks. Secondary objectives were to assess the safety, pharmacodynamics, and immunogenicity of ADI-PEG 20, as well as clinical efficacy with a secondary endpoint of overall survival.', 'detailedDescription': 'Subjects were enrolled sequentially (non-randomized) into two separate cohorts in parallel. Cohort 1 comprised subjects with "sensitive" disease and Cohort 2 comprised subjects with "refractory" disease. Both cohorts received the same treatment regimen consisting of 4 weekly IM administrations of ADI-PEG 20 (320 IU/m\\^2), followed by a 1-week follow-up (1 cycle). No dose adjustment was allowed. Additional treatment cycles were permitted in the absence of disease progression requiring other therapeutic interventions.\n\nEach cohort was to be enrolled in 2 stages. In the first stage, 15 subjects were to be accrued in Cohort 1 and 12 subjects in Cohort 2. If ≥ 3 subjects met the primary endpoint in Cohort 1, then an additional 13 subjects were to be accrued in the second stage. If ≤ 2 subjects met the primary endpoint in Cohort 1, then the study was to be terminated and declared negative for Cohort 1. If ≥ 1 subject met the primary endpoint in Cohort 2, then an additional 4 subjects were to be accrued in the second stage. If no subjects met the primary endpoint in Cohort 2, then the study was to be terminated and declared negative. Additionally, if at any time a death or two grade 4 adverse events (AEs) that were definitely related or probably related to the study drug occurred, then the study was to be stopped.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must have had histologically documented SCLC\n2. Assigned to one of two cohorts based on the following characteristics: Cohort 1: "Sensitive" disease subjects who had 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more; or Cohort 2: "Refractory" disease subjects, who had (a) 1 previous line of chemotherapy and either had no response or progressed in less than 90 days after completing treatment or (b) any subject ("sensitive" or "refractory") in need of third-line therapy, i.e., who completed or failed 2 previous lines of chemotherapy\n3. Measurable disease using RECIST version 1.1\n4. Argininosuccinate synthetase (ASS) tumor expression was either negative or \\< 5% + tumor cells by immunohistochemistry analysis\n5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2\n6. Laboratory parameters for vital functions in the normal range. Laboratory abnormalities that were not clinically significant were generally permitted, except for the following laboratory parameters, which were to be within the ranges specified:\n\n * Neutrophil count: ≥ 1.5 x 10\\^9/L\n * Lymphocyte count: ≥ 0.5 x 10\\^9/L\n * Platelet count: ≥ 50 x 10\\^9/L\n * Serum creatinine: ≤ 1.5 x upper limit of normal (ULN) (or creatinine clearance ≥ 60 mL/min)\n * Serum bilirubin: ≤ 2 mg/dL (or ≤ 34 µmol/L)\n * Serum uric acid: ≤ 8 mg/dL (or ≤ 0.48 mmol/L)\n * International normalized ratio (INR): ≤ 1.5\n * Partial thromboplastin time: ≤ 1.5 x ULN\n7. Age ≥ 18 years\n8. Able and willing to give valid written informed consent\n\nExclusion Criteria:\n\n1. Previous treatment with ADI-PEG 20\n2. Known allergy to pegylated products\n3. History of uncontrolled seizures\n4. Serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would interfere with the ability of the patient to fulfill the study requirements\n5. Metastatic disease to the central nervous system, unless treated and stable\n6. Known immunodeficiency or human immunodeficiency virus (HIV) positivity\n7. Participation in another clinical trial involving another investigational agent within 3 weeks prior to first dosing of study agent\n8. Any other malignancy that required protocol-specified restricted concomitant therapy\n9. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study\n10. Lack of availability for clinical follow-up assessment\n11. Pregnancy or breast feeding\n12. Refusal or inability to use effective means of contraception for men and women of childbearing potential for the duration of the study'}, 'identificationModule': {'nctId': 'NCT01266018', 'briefTitle': 'Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig Institute for Cancer Research'}, 'officialTitle': 'Phase II Study of ADI-PEG 20 in Patients With Relapsed Sensitive or Refractory Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'LUD2009-007'}, 'secondaryIdInfos': [{'id': 'Pro00022622', 'type': 'OTHER', 'domain': 'Duke University Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Sensitive Disease', 'description': 'Cohort 1 comprised subjects with "sensitive" disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more. Subjects received 4 administrations of ADI-PEG 20 (320 IU/m\\^2) followed by 1 week of follow-up in each treatment cycle.', 'interventionNames': ['Drug: ADI-PEG 20 (Arginine deiminase pegylated)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Refractory Disease', 'description': 'Cohort 2 comprised subjects with "refractory" disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed \\< 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response. Subjects received 4 administrations of ADI-PEG 20 (320 IU/m\\^2) followed by 1 week of follow-up in each treatment cycle.', 'interventionNames': ['Drug: ADI-PEG 20 (Arginine deiminase pegylated)']}], 'interventions': [{'name': 'ADI-PEG 20 (Arginine deiminase pegylated)', 'type': 'DRUG', 'otherNames': ['ADI', 'Arginine deiminase pegylated'], 'description': 'ADI-PEG 20 was administered intramuscularly (IM) at a fixed dose of 320 IU/m\\^2 (36.8 mg/m\\^2) once weekly for 4 weeks followed by a 1-week follow-up (1 cycle)', 'armGroupLabels': ['Cohort 1: Sensitive Disease', 'Cohort 2: Refractory Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': 'B-1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'University Clinic Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'D-60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Krankenhaus Nordwest', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital - LinKou Branch', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': 'EC1A 7BE', 'city': 'West Smithfield', 'state': 'London', 'country': 'United Kingdom', 'facility': "St. Bartholomew's Hospital"}], 'overallOfficials': [{'name': 'Lee M Krug, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig Institute for Cancer Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': "St. Bartholomew's Hospital", 'class': 'OTHER'}, {'name': 'Krankenhaus Nordwest', 'class': 'OTHER'}, {'name': 'Saint-Luc University Hospital', 'class': 'UNKNOWN'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'Austin Health', 'class': 'OTHER_GOV'}, {'name': 'Polaris Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}