Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-20 @ 10:42 PM
Study NCT ID:
NCT02544633
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2015-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tassellv@mirati.com', 'phone': '858-332-3438', 'title': 'Vanessa Tassell, Vice President, Clinical Science', 'organization': 'Mirati Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'PI can not disclose, discuss, or publish study results until final manuscript has been published.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early closure of the study is due to sponsor portfolio prioritization and not due to any patient safety issues.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'All Cause Mortality includes deaths that occurred in the Treatment Period and the Survival Follow-Up Period.', 'eventGroups': [{'id': 'EG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'deathsNumAffected': 12, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 14, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Total', 'description': 'All patients', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 67, 'seriousNumAtRisk': 68, 'deathsNumAffected': 38, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 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{'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 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'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 15}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Oesophagobronchial fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '2.27', 'upperLimit': '28.23'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '3.21', 'upperLimit': '37.89'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '3.19', 'upperLimit': '65.09'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '26.46'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000'], 'paramType': 'Objective response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.7', 'ciLowerLimit': '2.27', 'ciUpperLimit': '28.23', 'statisticalMethod': 'exact test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \\<=20% against H1: ORR \\>20%.'}, {'pValue': '0.79', 'groupIds': ['OG001'], 'paramType': 'Objective response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.0', 'ciLowerLimit': '3.21', 'ciUpperLimit': '37.89', 'statisticalMethod': 'exact test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG002'], 'paramType': 'Objective response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.0', 'ciLowerLimit': '3.19', 'ciUpperLimit': '65.09', 'statisticalMethod': 'Exact Test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.999', 'groupIds': ['OG003'], 'paramType': 'Objective response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0.00', 'ciUpperLimit': '26.46', 'statisticalMethod': 'Exact test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months', 'description': 'Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '132'}, {'value': '170', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '170'}, {'value': 'NA', 'comment': 'Median DR and upper bound of 95% CI for median DR are not estimable. Median not reached/small number of events.', 'groupId': 'OG002', 'lowerLimit': '77', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.', 'description': 'Duration of Response (DR) will be defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '4.18'}, {'value': '4.84', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '5.53'}, {'value': '3.39', 'comment': 'Upper bound of 95% CI for median PFS is not estimable due to small number of events.', 'groupId': 'OG002', 'lowerLimit': '1.28', 'upperLimit': 'NA'}, {'value': '2.76', 'groupId': 'OG003', 'lowerLimit': '1.48', 'upperLimit': '4.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.', 'description': 'Progression-free survival (PFS) will be defined as the time from date of first study treatment to first PD or death due to any cause in the absence of documented PD. Per RECIST 1.1, Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265'}, {'type': 'SECONDARY', 'title': '1-Year Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '50.47', 'groupId': 'OG000', 'lowerLimit': '27.49', 'upperLimit': '69.62'}, {'value': '34.92', 'groupId': 'OG001', 'lowerLimit': '14.05', 'upperLimit': '56.89'}, {'value': '54.69', 'groupId': 'OG002', 'lowerLimit': '13.72', 'upperLimit': '83.24'}, {'value': '13.89', 'groupId': 'OG003', 'lowerLimit': '0.86', 'upperLimit': '44.05'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first study treatment to death due to any cause, assessed up to 12 months', 'description': '1-Year Survival will be defined as the probability of survival at 1 year after the first dose.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '16.32', 'comment': 'Upper bound of 95% CI for median OS is not estimable due to small number of events.', 'groupId': 'OG000', 'lowerLimit': '4.01', 'upperLimit': 'NA'}, {'value': '7.04', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '14.93'}, {'value': 'NA', 'comment': 'Median OS and upper bound of 95% CI for median OS are not estimable. Median not reached/small number of events.', 'groupId': 'OG002', 'lowerLimit': '.89', 'upperLimit': 'NA'}, {'value': '4.08', 'groupId': 'OG003', 'lowerLimit': '1.22', 'upperLimit': '11.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first study treatment to death due to any cause, assessed up to 24 months.', 'description': 'Overall Survival will be defined as the time from date of first study treatment to death due to any cause', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.', 'description': 'Number of patients experiencing treatment-emergent adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - AUC0-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}], 'classes': [{'categories': [{'measurements': [{'value': '250.8', 'spread': '98.0', 'groupId': 'OG000'}, {'value': '1565', 'spread': '54.0', 'groupId': 'OG001'}, {'value': '185.5', 'spread': '98.8', 'groupId': 'OG002'}, {'value': '1837', 'spread': '51.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}, {'id': 'OG004', 'title': 'Tablet 750 mg BID C2D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 2 Day 1'}, {'id': 'OG005', 'title': 'Tablet 750 mg BID C2D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 2 Day 15'}, {'id': 'OG006', 'title': 'Soft Gel 1050 mg BID C2D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '69.77', 'spread': '87.1', 'groupId': 'OG000'}, {'value': '279.2', 'spread': '54.6', 'groupId': 'OG001'}, {'value': '60.49', 'spread': '103.9', 'groupId': 'OG002'}, {'value': '328.1', 'spread': '49.8', 'groupId': 'OG003'}, {'value': '214', 'spread': '69.4', 'groupId': 'OG004'}, {'value': '138', 'spread': '100.0', 'groupId': 'OG005'}, {'value': '386', 'spread': '13.9', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Ctrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}, {'id': 'OG004', 'title': 'Tablet 750 mg BID C2D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 2 Day 1'}, {'id': 'OG005', 'title': 'Tablet 750 mg BID C2D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 2 Day 15'}, {'id': 'OG006', 'title': 'Soft Gel 1050 mg BID C2D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 2 Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'spread': '52.5', 'groupId': 'OG001'}, {'value': '337', 'spread': '59.2', 'groupId': 'OG003'}, {'value': '203', 'spread': '80.9', 'groupId': 'OG004'}, {'value': '255', 'spread': '37.5', 'groupId': 'OG005'}, {'value': '345', 'spread': '48.5', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}], 'classes': [{'categories': [{'measurements': [{'value': '6.42', 'spread': '87.2', 'groupId': 'OG001'}, {'value': '9.88', 'spread': '96.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ratio AUC0-6 = AUC0-6 C1D15/ AUC0-6 C1D1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}], 'classes': [{'categories': [{'measurements': [{'value': '4.07', 'spread': '79.7', 'groupId': 'OG001'}, {'value': '5.35', 'spread': '100.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ration Cmax = Cmax C1D15/ Cmax C1D1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '10.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Peak to trough ratio calculated as C1D15 Cmax/Ctrough.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of MGCD265 - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tablet 750 mg BID C1D1', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 1'}, {'id': 'OG001', 'title': 'Tablet 750 mg BID C1D15', 'description': 'Tablet formulation, 750 mg, BID, Cycle 1 Day 15'}, {'id': 'OG002', 'title': 'Soft Gel 1050 mg BID C1D1', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 1'}, {'id': 'OG003', 'title': 'Soft Gel 1050 mg BID C1D15', 'description': 'Soft Gel formulation, 1050 mg, BID, Cycle 1 Day 15'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.'}, {'type': 'SECONDARY', 'title': 'Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations', 'description': 'Patients with MET Activating Mutations'}], 'classes': [{'categories': [{'title': 'Positive by both PCR and NGS', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Positive by PCR and Negative by NGS', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Negative by PCR and Positive by NGS', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Negative by both PCR and NGS', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Activating Mutations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Gene Amplifications', 'description': 'Patients with MET Gene Amplifications'}], 'classes': [{'categories': [{'title': 'Positive by both FISH and NGS', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Positive by FISH and Negative by NGS', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Negative by FISH and Positive by NGS', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Negative by both FISH and NGS', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Gene Amplifications.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutation', 'description': 'MET Exon 14 deletion mutation'}, {'id': 'OG001', 'title': 'MET Gene Amplification', 'description': 'MET activating mutation'}], 'classes': [{'title': 'Detected at Screening', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Detected at End of Treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and at time of confirmation of response to treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was closed early due to sponsor portfolio prioritization and not due to any patient safety issues. Based on limited individual patient data for whom baseline and post-treatment values were available, the statistical analyses as planned could not be performed. Screening and end of treatment detection results provided.'}, {'type': 'SECONDARY', 'title': 'Blood Plasma Concentration of Soluble MET (sMET) Biomarker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'OG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'OG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'OG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '443494.7', 'spread': '228345.48', 'groupId': 'OG000'}, {'value': '461985.2', 'spread': '122069.25', 'groupId': 'OG001'}, {'value': '450112.5', 'spread': '80809.29', 'groupId': 'OG002'}, {'value': '961383.1', 'spread': '1665608.92', 'groupId': 'OG003'}]}]}, {'title': 'Actual - Cycle 1 Day 15 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '577631.4', 'spread': '221350.47', 'groupId': 'OG000'}, {'value': '568938.8', 'spread': '129859.54', 'groupId': 'OG001'}, {'value': '594277.3', 'spread': '49746.18', 'groupId': 'OG002'}, {'value': '775242.8', 'spread': '679349.02', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline - Cycle 1 Day 15 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '122074.7', 'spread': '166978.07', 'groupId': 'OG000'}, {'value': '94110.4', 'spread': '87158.09', 'groupId': 'OG001'}, {'value': '144164.8', 'spread': '51740.94', 'groupId': 'OG002'}, {'value': '-257537.5', 'spread': '1102955.10', 'groupId': 'OG003'}]}]}, {'title': 'Actual - Cycle 2 Day 1 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '560790.3', 'spread': '216802.34', 'groupId': 'OG000'}, {'value': '582800.9', 'spread': '140742.66', 'groupId': 'OG001'}, {'value': '662385.3', 'spread': '41039.78', 'groupId': 'OG002'}, {'value': '742344.9', 'spread': '620417.99', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline - Cycle 2 Day 1 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '144802.6', 'spread': '158943.04', 'groupId': 'OG000'}, {'value': '120815.6', 'spread': '133979.33', 'groupId': 'OG001'}, {'value': '212272.8', 'spread': '86344.15', 'groupId': 'OG002'}, {'value': '-219038.2', 'spread': '1085522.39', 'groupId': 'OG003'}]}]}, {'title': 'Actual - Cycle 2 Day 15 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '551625.9', 'spread': '234249.28', 'groupId': 'OG000'}, {'value': '630505.5', 'spread': '133180.58', 'groupId': 'OG001'}, {'value': '482109.0', 'groupId': 'OG002'}, {'value': '628011.8', 'spread': '291532.85', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline - Cycle 2 Day 15 - Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96641.3', 'spread': '144021.14', 'groupId': 'OG000'}, {'value': '169374.6', 'spread': '70996.25', 'groupId': 'OG001'}, {'value': '44093.0', 'groupId': 'OG002'}, {'value': '184161.0', 'spread': '161224.04', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 and Cycle 2', 'description': 'MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacodynamics Evaluable Population Population defined as all patients in the mITT population for whom PD analytical results were available. Overall number of participants analyzed at baseline and post-baseline are different due to samples not being collected post-baseline for some patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'FG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'FG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'FG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Patient Still on Treatment/Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Global Deterioration of Health', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Clinical Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Survival Follow-up Period', 'milestones': [{'type': 'STARTED', 'comment': '2 patients on treatment at the time of primary report date', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': "Sponsor approval of each potential patient's genetic testing following prescreening, whether performed by the study central lab or a Sponsor-approved local lab, was filed prior to proceeding to full clinical screening. All patients considered eligible for the study following clinical screening were submitted to Sponsor for registration approval."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MET Activating Mutations in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in tumor tissue.'}, {'id': 'BG001', 'title': 'MET Gene Amplifications in Tumor Tissue', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in tumor tissue.'}, {'id': 'BG002', 'title': 'MET Activating Mutations in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET activating mutations in the blood (circulating tumor DNA).'}, {'id': 'BG003', 'title': 'MET Gene Amplifications in ctDNA', 'description': 'MGCD265 (750 mg BID spray dried dispersion tablet or 1050 mg BID soft-gel capsule) in patients with MET gene amplifications in the blood (circulating tumor DNA).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Mean (STD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '6.02', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '13.17', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '7.70', 'groupId': 'BG002'}, {'value': '64.8', 'spread': '11.09', 'groupId': 'BG003'}, {'value': '65.7', 'spread': '10.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '168.63', 'spread': '9.74', 'groupId': 'BG000'}, {'value': '173.18', 'spread': '8.77', 'groupId': 'BG001'}, {'value': '161.11', 'spread': '8.10', 'groupId': 'BG002'}, {'value': '167.70', 'spread': '8.98', 'groupId': 'BG003'}, {'value': '169.43', 'spread': '9.52', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some patients did not have height recorded at baseline'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '25.16', 'spread': '4.58', 'groupId': 'BG000'}, {'value': '24.92', 'spread': '4.46', 'groupId': 'BG001'}, {'value': '22.24', 'spread': '2.34', 'groupId': 'BG002'}, {'value': '21.80', 'spread': '4.18', 'groupId': 'BG003'}, {'value': '24.24', 'spread': '4.49', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI unable to be calculated in patients with no height recorded at baseline'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '70.85', 'spread': '17.64', 'groupId': 'BG000'}, {'value': '75.33', 'spread': '17.77', 'groupId': 'BG001'}, {'value': '60.97', 'spread': '8.68', 'groupId': 'BG002'}, {'value': '61.58', 'spread': '13.56', 'groupId': 'BG003'}, {'value': '69.37', 'spread': '16.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ECOG Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': '1', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0: Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. Capable of only limited self care, confined to bed or chair more than 50% of waking hours\n4. Completely disabled. Cannot carry on any self care. Totally confined to bed or chair\n5. Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Disease Histology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Adenocarcinoma', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Squamous Cell Carcinoma', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Large Cell Carcinoma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Locally Advanced', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Metastatic', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Lifetime Non-Smoker', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Past Smoker', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'These figures are based on the safety population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-23', 'size': 863079, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-30T16:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2015-09-04', 'resultsFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-06', 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Up to 3 months', 'description': 'Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response', 'timeFrame': 'From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.', 'description': 'Duration of Response (DR) will be defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.', 'description': 'Progression-free survival (PFS) will be defined as the time from date of first study treatment to first PD or death due to any cause in the absence of documented PD. Per RECIST 1.1, Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.'}, {'measure': '1-Year Survival Rate', 'timeFrame': 'From date of first study treatment to death due to any cause, assessed up to 12 months', 'description': '1-Year Survival will be defined as the probability of survival at 1 year after the first dose.'}, {'measure': 'Overall Survival', 'timeFrame': 'From date of first study treatment to death due to any cause, assessed up to 24 months.', 'description': 'Overall Survival will be defined as the time from date of first study treatment to death due to any cause'}, {'measure': 'Number of Patients Experiencing Treatment-emergent Adverse Events', 'timeFrame': 'Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.', 'description': 'Number of patients experiencing treatment-emergent adverse events.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - AUC0-6', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Cmax', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Ctrough', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ratio AUC0-6 = AUC0-6 C1D15/ AUC0-6 C1D1.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ration Cmax = Cmax C1D15/ Cmax C1D1.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Peak to trough ratio calculated as C1D15 Cmax/Ctrough.'}, {'measure': 'Blood Plasma Concentration of MGCD265 - Tmax', 'timeFrame': 'Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.', 'description': 'Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.'}, {'measure': 'Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations', 'timeFrame': 'At baseline', 'description': 'Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Activating Mutations.'}, {'measure': 'Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications', 'timeFrame': 'At baseline', 'description': 'Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Gene Amplifications.'}, {'measure': 'Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population', 'timeFrame': 'At baseline and at time of confirmation of response to treatment'}, {'measure': 'Blood Plasma Concentration of Soluble MET (sMET) Biomarker', 'timeFrame': 'Cycle 1 and Cycle 2', 'description': 'MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mirati', 'MGCD265', 'MET', 'NSCLC'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '38417277', 'type': 'DERIVED', 'citation': 'Hong DS, Cappuzzo F, Chul Cho B, Dowlati A, Hussein M, Kim DW, Percent I, Christensen JG, Morin J, Potvin D, Faltaos D, Tassell V, Der-Torossian H, Chao R. Phase II study investigating the efficacy and safety of glesatinib (MGCD265) in patients with advanced NSCLC containing MET activating alterations. Lung Cancer. 2024 Apr;190:107512. doi: 10.1016/j.lungcan.2024.107512. Epub 2024 Feb 22.'}, {'pmid': '36459255', 'type': 'DERIVED', 'citation': 'Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification \\[increase number of gene copies\\]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.', 'detailedDescription': 'If testing has not already been performed, the study will provide for the testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of non-small cell lung cancer\n* Metastatic or locally advanced disease\n* Prior platinum chemotherapy or immunotherapy\n* Test result showing genetic change in MET tumor gene\n* At least one tumor that can be measured on a radiographic scan\n\nExclusion Criteria:\n\n* Prior treatment with inhibitor of MET or HGF\n* Prior positive test for EGFR mutation or ALK gene rearrangement\n* Uncontrolled tumor in the brain'}, 'identificationModule': {'nctId': 'NCT02544633', 'briefTitle': 'Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'Phase 2, Parallel-Arm Study of MGCD265 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor', 'orgStudyIdInfo': {'id': '265-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'MGCD265 in patients with MET activating mutations in tumor tissue', 'interventionNames': ['Drug: MGCD265']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'MGCD265 in patients with MET gene amplifications in tumor tissue', 'interventionNames': ['Drug: MGCD265']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)', 'interventionNames': ['Drug: MGCD265']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)', 'interventionNames': ['Drug: MGCD265']}], 'interventions': [{'name': 'MGCD265', 'type': 'DRUG', 'description': 'MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clearview Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Fowler Family Center for Cancer Care', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Saint Joseph Medical Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92835-3825', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Saint Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92121', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Reseach Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "St. Mary's Regional Cancer Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology and Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital - Eugene M. & Christine E. 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