Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-26 @ 2:19 AM
Study NCT ID:
NCT02495233
Status:
TERMINATED
Last Update Posted:
2024-11-27
First Post:
2015-07-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609080', 'term': 'gilteritinib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '800-888-7704', 'title': 'Clinical Trial Disclosure', 'organization': 'Astellas Pharma Global Development, Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)', 'description': 'Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.', 'eventGroups': [{'id': 'EG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oral dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aldolase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myoglobin blood increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acne pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle ≥2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 and Cycle ≥2 (up to 141 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs. DLT evaluable set (DES), was a subset of SAF and included participants who were either administered with at least 75% of planned dose during cycle 1 or experienced DLT during cycle 1.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related serious TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs leading to withdrawal of treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related TEAEs leading to withdrawal of treat.', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)', 'description': 'Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2950', 'spread': '1128', 'groupId': 'OG000'}, {'value': '1885', 'spread': '685.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12203', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '8342', 'spread': '3023', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set (PKAS) consisted of all participants who received at least 1 dose of study drugs for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known.'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) for Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '210.3', 'spread': '107.4', 'groupId': 'OG000'}, {'value': '119', 'spread': '47.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '637', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '408.3', 'spread': '136.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Cycle 1 Day 1,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.961', 'spread': '0.08221', 'groupId': 'OG000'}, {'value': '3.762', 'spread': '0.8109', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '4.594', 'spread': '1.044', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Predose on Day 1 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 3 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '110.2', 'spread': '46.51', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 8 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '261.3', 'spread': '31.66', 'groupId': 'OG000'}, {'value': '282.9', 'spread': '136.7', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 15 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '491.7', 'spread': '430.5', 'groupId': 'OG000'}, {'value': '397', 'spread': '208.9', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 22 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '466.3', 'spread': '128.2', 'groupId': 'OG000'}, {'value': '414.8', 'spread': '186.1', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 28 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '430', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '241.3', 'spread': '114.4', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 1 of cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161', 'spread': '38.18', 'groupId': 'OG001'}]}]}, {'title': 'Predose on Day 1 of cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '236', 'spread': '104.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4', 'description': 'All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'AUC24 of Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '34580', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '54055', 'spread': '22962', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Cmax of Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3050', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '3160', 'spread': '314.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Tmax of Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '2.633', 'spread': '1.185', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Ctrough of Erlotinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'title': 'Predose of Day 8 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1004', 'spread': '758.7', 'groupId': 'OG000'}, {'value': '1827', 'spread': '1392', 'groupId': 'OG001'}]}]}, {'title': 'Predose of Day 15 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1427', 'spread': '1596', 'groupId': 'OG000'}, {'value': '2098', 'spread': '1637', 'groupId': 'OG001'}]}]}, {'title': 'Predose of Day 22 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '942.7', 'spread': '116', 'groupId': 'OG000'}, {'value': '1999', 'spread': '1285', 'groupId': 'OG001'}]}]}, {'title': 'Predose of Day 28 of cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '909', 'spread': 'NA', 'comment': 'There was only 1 subject, the mean was the value for that 1 subject. The SD could not be calculated so NA would be entered.', 'groupId': 'OG000'}, {'value': '1368', 'spread': '1255', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, 15, 22, 28 of cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) in Phase 1b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'OG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (approximately 4 months)', 'description': 'ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ASAT consisted of all participants allocated to treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'FG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with Epidermal growth factor receptor (EGFR) activating mutation-positive (EGFRm+) advanced NSCLC who have acquired resistance to an EGFR Tyrosine kinase inhibitor (TKI) were enrolled in 4 study sites in Japan.', 'preAssignmentDetails': 'Eligible participants received gilteritinib in combination with erlotinib 150 mg. At least 3, and no more than 12, dose-limiting toxicity (DLT)-evaluable patients were to be enrolled in a given dose cohort. Dose escalation, cohort expansion or de-escalation decisions were to be guided by a modified toxicity probability interval design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'BG001', 'title': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '61.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Study terminated due to adverse events related to the combination therapy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2017-09-14', 'completionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2015-07-08', 'dispFirstSubmitQcDate': '2017-09-14', 'resultsFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2015-07-08', 'dispFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-21', 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 and Cycle ≥2 (up to 141 days)'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)', 'description': 'Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1'}, {'measure': 'Maximum Concentration (Cmax) for Gilteritinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1'}, {'measure': 'Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1'}, {'measure': 'Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib', 'timeFrame': 'Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4', 'description': 'All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.'}, {'measure': 'AUC24 of Erlotinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1'}, {'measure': 'Cmax of Erlotinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1'}, {'measure': 'Tmax of Erlotinib', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1'}, {'measure': 'Ctrough of Erlotinib', 'timeFrame': 'Day 8, 15, 22, 28 of cycle 1'}, {'measure': 'Objective Response Rate (ORR) in Phase 1b', 'timeFrame': 'End of treatment (approximately 4 months)', 'description': 'ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erlotinib', 'ASP2215', 'NSCLC', 'Gilteritinib', 'Non-Small-Cell Lung Cancer'], 'conditions': ['Non-Small-Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=286', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.', 'detailedDescription': 'No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "IInclusion Criteria:\n\n* Participant had histologically or cytologically confirmed metastatic or locally advanced, unresectable non-small-cell lung cancer (NSCLC).\n* Participant had a documented exon 19 deletion or exon 21 L858R EGFR activating mutation.\n* Participant had received prior treatment with any EGFR tyrosine kinase inhibitor\n* Participant had Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 at screening.\n* Participant had adequate organ function.\n* Female participant must either:\n\n * Be of nonchildbearing potential:\n * Or, if of childbearing potential,\n\n 1. Agree not to try to become pregnant during the study and for 45 days after the final study drug administration\n 2. And had a negative serum pregnancy test at screening\n 3. And, if heterosexually active, agreed to consistently use 2 forms of highly effective birth control\n* Male participant and their female spouse/partners who were of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control\n* Phase 1b Participants only:\n\n * Participant was not expected to show a therapeutic response to existing available treatment.\n * Intervening anticancer treatment subsequent to the EGFR TKI was allowed (but not required).\n* Additional inclusion criteria for phase 2 Participants only:\n\n * Participant had a NSCLC tissue sample obtained after participant developed resistance to EGFR TKI therapy that was available for central testing.\n * Participant's baseline tumor specimen (obtained after participant developed resistance to EGFR TKI therapy) is T790M negative.\n * Participant received an EGFR TKI for at least 6 months and progressed on this therapy within the past 28 days.\n * Participant had not had any intervening anticancer treatment subsequent to the EGFR TKI with the exception of radiotherapy which was allowed if it occurred at least 14 days prior to the first dose of study drug.\n * Participant had at least 1 measureable lesion (not including any lesion that was irradiated) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nExclusion Criteria:\n\n* Participant had an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening.\n* Participant received any agent with antitumor activity (other than an EGFR inhibitor, including a T790M inhibitor) including chemotherapy, radiotherapy, immunotherapy, within 14 days prior to the first dose of study drug (palliative radiotherapy is allowed).\n* Participant received ASP2215 previously.\n* Participant received blood transfusions or hematopoietic growth factor therapy within 14 days prior to the first dose of study drug.\n* Participant had a major surgical procedure (other than study-related biopsy) within 14 days prior to the first dose of study drug, or a major surgical procedure was planned to occur during the study.\n* Participant had active hepatitis B or C or other active hepatic disorder.\n* Participant t was known to have human immunodeficiency virus (HIV) infection.\n* Participant had symptomatic central nervous system (CNS) metastasis. Participants with asymptomatic, untreated CNS metastases were allowed. Participants with previously treated and currently asymptomatic CNS metastases were eligible provided they met the following:\n\n * Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the first dose of study drug.\n * Any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug.\n * Participant did not require steroids or did not require escalating doses of steroids for at least 2 weeks prior to the first dose of study drug.\n* Participant had evidence of active infection requiring systemic therapy within 14 days prior to the first dose of study drug.\n* Participant had uncontrolled hypertension.\n* Participant had severe or uncontrolled systemic diseases or active bleeding diatheses.\n* Participant had history of drug-induced interstitial lung disease or any evidence of active interstitial lung disease.\n* Participant had ongoing cardiac arrhythmia (including atrial fibrillation) that was grade ≥ 2.\n* Participant currently had Class 3 or 4 New York Heart Association congestive heart failure.\n* Participant had history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the first dose of study drug.\n* Participant had history of gastrointestinal ulcer within 28 days prior to the first dose of study drug.\n* Participant had a history of gastrointestinal bleeding within 90 days prior to the first dose of study drug.\n* Participant had concurrent corneal disorder or any ophthalmologic condition which makes the participant unsuitable for study participation .\n* Participant had any condition which made the participant unsuitable for study participation.\n* Participant had hypokalemia or hypomagnesemia at screening.\n* Participant had QTcF interval \\> 450 ms on 12-lead ECG at screening.\n* Participant was known to have long QT syndrome.\n* Participant was taking medication known to prolong the QT interval."}, 'identificationModule': {'nctId': 'NCT02495233', 'briefTitle': 'A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)', 'orgStudyIdInfo': {'id': '2215-CL-5101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 120mg + Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Erlotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Gilteritinib 80mg+ Erlotinib 150mg', 'description': 'Gilteritinib was administered in combination with erlotinib orally once daily.', 'interventionNames': ['Drug: Gilteritinib', 'Drug: Erlotinib']}], 'interventions': [{'name': 'Gilteritinib', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Gilteritinib 120mg + Erlotinib 150mg', 'Gilteritinib 80mg+ Erlotinib 150mg']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'oral', 'armGroupLabels': ['Gilteritinib 120mg + Erlotinib 150mg', 'Gilteritinib 80mg+ Erlotinib 150mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka Minami-ku, Fukuoka', 'country': 'Japan', 'facility': 'Site JP81004', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Osakasayama, Osaka', 'country': 'Japan', 'facility': 'Site JP81005'}, {'city': 'Suntogun Nagaizumicho,Shizuoka', 'country': 'Japan', 'facility': 'Site JP81003', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP81002', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Senior Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}