Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-04 @ 8:31 AM
Study NCT ID:
NCT01526928
Status:
TERMINATED
Last Update Posted:
2020-08-04
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589977', 'term': 'rociletinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@clovisoncology.com', 'phone': '+1 415 409 7220', 'title': 'Medical Information Department', 'organization': 'Clovis Oncology'}, 'certainAgreement': {'otherDetails': 'All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 42 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before first dose of study drug were expected to be reported. Any Serious Adverse Events or Adverse Events of Special Interest were followed until resolution or stabilization, or until patient is lost to follow-up.', 'description': 'If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).', 'eventGroups': [{'id': 'EG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 37, 'seriousNumAtRisk': 38, 'deathsNumAffected': 4, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 4, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 208, 'seriousNumAtRisk': 209, 'deathsNumAffected': 31, 'seriousNumAffected': 106}, {'id': 'EG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 244, 'seriousNumAtRisk': 245, 'deathsNumAffected': 40, 'seriousNumAffected': 138}, {'id': 'EG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 95, 'seriousNumAtRisk': 95, 'deathsNumAffected': 19, 'seriousNumAffected': 54}, {'id': 'EG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 74}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dysacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 94}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 121}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 146}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 54}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 95}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 138}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 51}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 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{'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Subgaleal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of T790M Positive Patients With Confirmed Response Per Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '176', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 42 months', 'description': 'Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat: All randomized patients who are confirmed by central lab to be T790M positive'}, {'type': 'PRIMARY', 'title': 'Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID)'}, {'id': 'OG001', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)'}, {'id': 'OG002', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)'}, {'id': 'OG003', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)'}, {'id': 'OG004', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '329.0', 'groupId': 'OG000', 'lowerLimit': '190.0', 'upperLimit': '713.0'}, {'value': '275.0', 'groupId': 'OG001', 'lowerLimit': '226.0', 'upperLimit': '336.0'}, {'value': '274.0', 'groupId': 'OG002', 'lowerLimit': '169.0', 'upperLimit': '337.0'}, {'value': '217.0', 'groupId': 'OG003', 'lowerLimit': '146.0', 'upperLimit': '340.0'}, {'value': '428', 'comment': 'There are an insufficient number of participants with events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 36 months', 'description': 'Duration of Response in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The DOR was measured only in T790M positive patients with a Complete Response (CR) or Partial Response (PR). There were no responders in the Rociletinib \\<900 mg BID treatment group so DOR is not applicable and thus not reported.'}, {'type': 'PRIMARY', 'title': 'Dose Limiting Toxicity (DLT) Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 21', 'description': 'The number of Phase 1 patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The dose limiting toxicity (DLT) evaluable population includes all patients who have completed Cycle 1, and who were enrolled while the dose escalation (Phase 1) part of the study was ongoing.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Determined by Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID)'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID)'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '17.9'}, {'value': '23.7', 'comment': 'There are an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': 'NA'}, {'value': '18.5', 'comment': 'There are an insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': 'NA'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '12.5', 'upperLimit': '17.3'}, {'value': '12.9', 'groupId': 'OG004', 'lowerLimit': '9.9', 'upperLimit': '17.7'}, {'value': '7.2', 'comment': 'There are an insufficient number of participants with events.', 'groupId': 'OG005', 'lowerLimit': '2.2', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to date of death, assessed up to 42 months', 'description': 'Overall survival was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the \\<900 mg BID FB group, and 1 less patient in each of the 500, 625 and 750 mg BID dose groups because they were not followed for OS.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID)'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID)'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.0'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '12.2'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '6.2'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '6.2'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '6.1'}, {'value': '7.2', 'groupId': 'OG005', 'lowerLimit': '2.2', 'upperLimit': '16.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 42 months', 'description': 'Progression-free survival was calculated as the number of days from the date of the first dose of study drug to the date of disease progression or death due to any cause + 1. Patients without a documented event of disease progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments have been performed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the \\<900 mg BID FB group, and 1 less patient in each of the 500 and 625 mg BID dose groups because they were not followed for PFS.'}, {'type': 'SECONDARY', 'title': 'PK Profile of Rociletinib - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 150 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 150 mg once a day (QD).'}, {'id': 'OG001', 'title': 'Rociletinib 200 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 200 mg once a day (QD).'}, {'id': 'OG002', 'title': 'Rociletinib 300 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg once a day (QD).'}, {'id': 'OG003', 'title': 'Rociletinib 450 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 450 mg once a day (QD).'}, {'id': 'OG004', 'title': 'Rociletinib 600 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg once a day (QD).'}, {'id': 'OG005', 'title': 'Rociletinib 900 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg once a day (QD).'}, {'id': 'OG006', 'title': 'Rociletinib 100 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 100 mg twice a day (BID).'}, {'id': 'OG007', 'title': 'Rociletinib 300 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg twice a day (BID).'}, {'id': 'OG008', 'title': 'Rociletinib 600 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg twice a day (BID).'}, {'id': 'OG009', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG010', 'title': 'Rociletinib 400 mg TID FB Capsules', 'description': 'Rociletinib free base (FB) dose 400 mg three times a day (TID).'}, {'id': 'OG011', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG012', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG013', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG014', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'title': 'Day 1 Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '537', 'spread': '71', 'groupId': 'OG000'}, {'value': '533', 'spread': '63', 'groupId': 'OG001'}, {'value': '1290', 'spread': '1019', 'groupId': 'OG002'}, {'value': '1800', 'spread': '1224', 'groupId': 'OG003'}, {'value': '969', 'spread': '824', 'groupId': 'OG004'}, {'value': '2470', 'spread': '1482', 'groupId': 'OG005'}, {'value': '574', 'spread': '293', 'groupId': 'OG006'}, {'value': '706', 'spread': '88', 'groupId': 'OG007'}, {'value': '1680', 'spread': '1126', 'groupId': 'OG008'}, {'value': '1650', 'spread': '809', 'groupId': 'OG009'}, {'value': '704', 'spread': '352', 'groupId': 'OG010'}, {'value': '2800', 'spread': '2128', 'groupId': 'OG011'}, {'value': '2980', 'spread': '2235', 'groupId': 'OG012'}, {'value': '2570', 'spread': '1850', 'groupId': 'OG013'}, {'value': '4250', 'spread': '2678', 'groupId': 'OG014'}]}]}, {'title': 'Day 15 Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '16', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '250', 'spread': '188', 'groupId': 'OG000'}, {'value': '503', 'spread': '377', 'groupId': 'OG001'}, {'value': '1760', 'spread': '1056', 'groupId': 'OG002'}, {'value': '942', 'spread': '857', 'groupId': 'OG003'}, {'value': '981', 'spread': '343', 'groupId': 'OG004'}, {'value': '2200', 'spread': '1100', 'groupId': 'OG005'}, {'value': '729', 'spread': '576', 'groupId': 'OG006'}, {'value': '647', 'spread': '304', 'groupId': 'OG007'}, {'value': '928', 'spread': '95', 'groupId': 'OG008'}, {'value': '1510', 'spread': '997', 'groupId': 'OG009'}, {'value': '1140', 'spread': '274', 'groupId': 'OG010'}, {'value': '2330', 'spread': '1375', 'groupId': 'OG011'}, {'value': '3070', 'spread': '2272', 'groupId': 'OG012'}, {'value': '2100', 'spread': '1029', 'groupId': 'OG013'}, {'value': '2510', 'spread': '728', 'groupId': 'OG014'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'Cmax = maximum concentration following administration of rociletinib', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.'}, {'type': 'SECONDARY', 'title': 'PK Profile of Rociletinib - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 150 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 150 mg once a day (QD).'}, {'id': 'OG001', 'title': 'Rociletinib 200 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 200 mg once a day (QD).'}, {'id': 'OG002', 'title': 'Rociletinib 300 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg once a day (QD).'}, {'id': 'OG003', 'title': 'Rociletinib 450 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 450 mg once a day (QD).'}, {'id': 'OG004', 'title': 'Rociletinib 600 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg once a day (QD).'}, {'id': 'OG005', 'title': 'Rociletinib 900 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg once a day (QD).'}, {'id': 'OG006', 'title': 'Rociletinib 100 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 100 mg twice a day (BID).'}, {'id': 'OG007', 'title': 'Rociletinib 300 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg twice a day (BID).'}, {'id': 'OG008', 'title': 'Rociletinib 600 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg twice a day (BID).'}, {'id': 'OG009', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG010', 'title': 'Rociletinib 400 mg TID FB Capsules', 'description': 'Rociletinib free base (FB) dose 400 mg three times a day (TID).'}, {'id': 'OG011', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG012', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG013', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG014', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'title': 'Day 1 Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '23', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '6'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '4'}, {'value': '4.0', 'groupId': 'OG007', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '4.0', 'groupId': 'OG008', 'lowerLimit': '2.5', 'upperLimit': '6'}, {'value': '4.0', 'groupId': 'OG009', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG010', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '1.5', 'groupId': 'OG011', 'lowerLimit': '0.5', 'upperLimit': '10'}, {'value': '2.5', 'groupId': 'OG012', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG013', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '3.25', 'groupId': 'OG014', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Day 15 Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '16', 'groupId': 'OG011'}, {'value': '16', 'groupId': 'OG012'}, {'value': '22', 'groupId': 'OG013'}, {'value': '5', 'groupId': 'OG014'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '4'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '6'}, {'value': '4.0', 'groupId': 'OG005', 'lowerLimit': '1.5', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'OG006', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2.5', 'groupId': 'OG008', 'lowerLimit': '2.5', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG009', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '10', 'groupId': 'OG010', 'lowerLimit': '10', 'upperLimit': '10'}, {'value': '2.5', 'groupId': 'OG011', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2.5', 'groupId': 'OG012', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2.5', 'groupId': 'OG013', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '1.5', 'groupId': 'OG014', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'Tmax = time to maximum concentration following administration of rociletinib', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.'}, {'type': 'SECONDARY', 'title': 'PK Profile of Rociletinib - AUC 0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '21', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 150 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 150 mg once a day (QD).'}, {'id': 'OG001', 'title': 'Rociletinib 200 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 200 mg once a day (QD).'}, {'id': 'OG002', 'title': 'Rociletinib 300 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg once a day (QD).'}, {'id': 'OG003', 'title': 'Rociletinib 450 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 450 mg once a day (QD).'}, {'id': 'OG004', 'title': 'Rociletinib 600 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg once a day (QD).'}, {'id': 'OG005', 'title': 'Rociletinib 900 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg once a day (QD).'}, {'id': 'OG006', 'title': 'Rociletinib 100 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 100 mg twice a day (BID).'}, {'id': 'OG007', 'title': 'Rociletinib 300 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg twice a day (BID).'}, {'id': 'OG008', 'title': 'Rociletinib 600 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg twice a day (BID).'}, {'id': 'OG009', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG010', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG011', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG012', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG013', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'title': 'Day 1 AUC 0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '16', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}, {'value': '19', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '2900', 'spread': '290', 'groupId': 'OG000'}, {'value': '5330', 'spread': '5880', 'groupId': 'OG001'}, {'value': '8370', 'spread': '6612', 'groupId': 'OG002'}, {'value': '8850', 'spread': '6461', 'groupId': 'OG003'}, {'value': '5840', 'spread': '3387', 'groupId': 'OG004'}, {'value': '13300', 'spread': '6650', 'groupId': 'OG005'}, {'value': '5740', 'spread': '2927', 'groupId': 'OG006'}, {'value': '8470', 'spread': '1008', 'groupId': 'OG007'}, {'value': '20400', 'spread': '12444', 'groupId': 'OG008'}, {'value': '16000', 'spread': '8960', 'groupId': 'OG009'}, {'value': '26800', 'spread': '13668', 'groupId': 'OG010'}, {'value': '33100', 'spread': '26149', 'groupId': 'OG011'}, {'value': '30300', 'spread': '16968', 'groupId': 'OG012'}, {'value': '50100', 'spread': '35070', 'groupId': 'OG013'}]}]}, {'title': 'Day 15 AUC 0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '20', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '1540', 'spread': '970', 'groupId': 'OG000'}, {'value': '3510', 'spread': '2620', 'groupId': 'OG001'}, {'value': '12100', 'spread': '11616', 'groupId': 'OG002'}, {'value': '4490', 'spread': '3817', 'groupId': 'OG003'}, {'value': '4800', 'spread': '2256', 'groupId': 'OG004'}, {'value': '11500', 'spread': '6555', 'groupId': 'OG005'}, {'value': '7100', 'spread': '4189', 'groupId': 'OG006'}, {'value': '6080', 'spread': '4560', 'groupId': 'OG007'}, {'value': '12100', 'spread': '1404', 'groupId': 'OG008'}, {'value': '17500', 'spread': '10675', 'groupId': 'OG009'}, {'value': '23700', 'spread': '13035', 'groupId': 'OG010'}, {'value': '31700', 'spread': '18386', 'groupId': 'OG011'}, {'value': '25800', 'spread': '14190', 'groupId': 'OG012'}, {'value': '28200', 'spread': '16638', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'AUC 0-24 = area under the curve from 0 to 24 hours', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. AUC was not calculated for patients in the 400 mg TID treatment group.'}, {'type': 'SECONDARY', 'title': 'PK Profile of Rociletinib - T 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '18', 'groupId': 'OG010'}, {'value': '21', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 150 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 150 mg once a day (QD).'}, {'id': 'OG001', 'title': 'Rociletinib 200 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 200 mg once a day (QD).'}, {'id': 'OG002', 'title': 'Rociletinib 300 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg once a day (QD).'}, {'id': 'OG003', 'title': 'Rociletinib 450 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 450 mg once a day (QD).'}, {'id': 'OG004', 'title': 'Rociletinib 600 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg once a day (QD).'}, {'id': 'OG005', 'title': 'Rociletinib 900 mg QD FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg once a day (QD).'}, {'id': 'OG006', 'title': 'Rociletinib 100 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 100 mg twice a day (BID).'}, {'id': 'OG007', 'title': 'Rociletinib 300 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 300 mg twice a day (BID).'}, {'id': 'OG008', 'title': 'Rociletinib 600 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 600 mg twice a day (BID).'}, {'id': 'OG009', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG010', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG011', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG012', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG013', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'title': 'Day 1 T 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '15', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '18', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '4.4', 'spread': '0.9', 'groupId': 'OG004'}, {'value': '3.5', 'spread': '2.8', 'groupId': 'OG005'}, {'value': '3.0', 'spread': '0.8', 'groupId': 'OG006'}, {'value': '3.5', 'spread': '1.0', 'groupId': 'OG007'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG008'}, {'value': '2.8', 'spread': '0.7', 'groupId': 'OG009'}, {'value': '2.7', 'spread': '0.7', 'groupId': 'OG010'}, {'value': '3.5', 'spread': '1.5', 'groupId': 'OG011'}, {'value': '3.1', 'spread': '1.5', 'groupId': 'OG012'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'OG013'}]}]}, {'title': 'Day 15 T 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '14', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '19', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '2.5', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '2.2', 'groupId': 'OG004'}, {'value': '3.5', 'spread': '.56', 'groupId': 'OG005'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'OG006'}, {'value': '2.9', 'spread': '0.7', 'groupId': 'OG007'}, {'value': '4.7', 'spread': '3.4', 'groupId': 'OG008'}, {'value': '2.7', 'spread': '1.9', 'groupId': 'OG009'}, {'value': '3.0', 'spread': '1.6', 'groupId': 'OG010'}, {'value': '3.2', 'spread': '0.8', 'groupId': 'OG011'}, {'value': '3.6', 'spread': '3.1', 'groupId': 'OG012'}, {'value': '3.9', 'spread': '1.9', 'groupId': 'OG013'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'T 1/2 = elimination half-life following administration of rociletinib', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. Elimination half-life was not calculated for patients in the 400 mg TID treatment group.'}, {'type': 'SECONDARY', 'title': 'Food Effect on PK of Rociletinib - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cmax Fasting', 'description': 'Rociletinib 150 mg FB single dose given while fasting'}, {'id': 'OG001', 'title': 'Cmax Fed', 'description': 'Rociletinib 150 mg FB single dose given with a high-fat breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '727', 'spread': '354', 'groupId': 'OG000'}, {'value': '1873', 'spread': '2570', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'Cmax = maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of 3 patients treated with rociletinib 150 mg FB capsules'}, {'type': 'SECONDARY', 'title': 'Food Effect on PK of Rociletinib - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tmax Fasting', 'description': 'Rociletinib 150 mg FB single dose given while fasting'}, {'id': 'OG001', 'title': 'Tmax Fed', 'description': 'Rociletinib 150 mg FB single dose given with a high-fat breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.5'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'Tmax = time to maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of 3 patients treated with rociletinib 150 mg FB capsules'}, {'type': 'SECONDARY', 'title': 'Food Effect on PK of Rociletinib - AUC 0-24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AUC 0-24 Fasting', 'description': 'Rociletinib 150 mg FB single dose given while fasting'}, {'id': 'OG001', 'title': 'AUC 0-24 Fed', 'description': 'Rociletinib 150 mg FB single dose given with a high-fat breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '4780', 'spread': '3625', 'groupId': 'OG000'}, {'value': '4455', 'spread': '2256', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'AUC 0-24 = area under the curve from 0 to 24 hours. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of 3 patients treated with rociletinib 150 mg FB capsules. AUC could not be determined for 1 patient in the Fed arm.'}, {'type': 'SECONDARY', 'title': 'Food Effect on PK of Rociletinib - C24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C24 Fasting', 'description': 'Rociletinib 150 mg FB single dose given while fasting'}, {'id': 'OG001', 'title': 'C24 Fed', 'description': 'Rociletinib 150 mg FB single dose given with a high-fat breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'spread': '22', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'C24 = rociletinib plasma concentration at 24 hours post the morning dose. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of 3 patients treated with rociletinib 150 mg FB capsules'}, {'type': 'SECONDARY', 'title': 'Food Effect on PK of Rociletinib - T 1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T 1/2 Fasting', 'description': 'Rociletinib 150 mg FB single dose given while fasting'}, {'id': 'OG001', 'title': 'T 1/2 Fed', 'description': 'Rociletinib 150 mg FB single dose given with a high-fat breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1', 'groupId': 'OG000'}, {'value': '3.1', 'spread': 'NA', 'comment': 'Data for one patient only so standard deviation not applicable.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'T 1/2 = elimination half-life following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of 3 patients treated with rociletinib 150 mg FB capsules. Data did not allow the calculation of half-life with high fat mean in 2 patients.'}, {'type': 'SECONDARY', 'title': 'QTcF Values Post Baseline by Daily Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '245', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'categories': [{'title': 'QTcF Post-Baseline <450 msec', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'QTcF Post-Baseline 450-480 msec', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'QTcF Post-Baseline 481-500 msec', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'QTcF Post-Baseline >=501 msec', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening to End of Treatment, up to approximately 42 months', 'description': "Frequency of QT interval prolongation by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population by daily dose'}, {'type': 'SECONDARY', 'title': 'QTcF Value Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '245', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'OG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'OG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'OG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}], 'classes': [{'categories': [{'title': 'QTcF Change from Baseline <=30 msec', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'QTcF Change from Baseline 30-60 msec', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'QTcF Change from Baseline >60 msec', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening to End of Treatment, up to approximately 42 months', 'description': "QTcF value change from baseline by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population by daily dose'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR), Duration of Response (DOR) and Progression-Free Survival (PFS) Per RECIST Version 1.1 as Determined by IRR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'OG001', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}], 'timeFrame': 'Cycle 1 Day 1 to End of Treatment / End of Follow-up', 'description': 'Objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) per RECIST Version 1.1 as determined by independent radiology review (IRR)', 'reportingStatus': 'POSTED', 'populationDescription': 'Tumor scans were collected for independent evaluation, however ORR, DOR and PFS analyses were not performed by the central reader since the sponsor deemed not necessary following early study termination. Therefore, all IRR outcome measures were not collected and can not be reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID). FB doses tested ranged from 150 mg once a day (QD) up to 900 mg twice a day (BID). This arm also includes a 400 mg three times a day (TID) dose. Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}, {'id': 'FG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID). Rociletinib FB capsules were administered in Phase 1 only (until November 2013) and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day treatment cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}, {'id': 'FG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}, {'id': 'FG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}, {'id': 'FG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}, {'id': 'FG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID). Rociletinib hydrobromide (HBr) tablets were administered in Phase 1 (starting in August 2013) and in all Phase 2 cohorts and were provided in 50 mg or 150 mg white capsules. Patients were instructed to take each dose with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Patients received rociletinib in 21-day cycles and were treated until there was progression by RECIST v1.1, clinical tumor progression, or unacceptable toxicity, or other discontinuation criteria were met. Patients could opt to continue to receive treatment with rociletinib following radiographic progression as outlined in the National Comprehensive Cancer Network (NCCN) guidelines for treatment of NSCLC with EGFR-TKIs if the patient provided consent, and the investigator and sponsor approved.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Total', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '209'}, {'groupId': 'FG003', 'numSubjects': '245'}, {'groupId': 'FG004', 'numSubjects': '95'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Started Phase 1', 'comment': 'Upon completion of Cycle 1, Phase 1 pts could participate in an optional Treatment-extension Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Started Phase 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '228'}, {'groupId': 'FG004', 'numSubjects': '82'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '209'}, {'groupId': 'FG003', 'numSubjects': '245'}, {'groupId': 'FG004', 'numSubjects': '95'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '182'}, {'groupId': 'FG004', 'numSubjects': '76'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'There were 612 patients who received rociletinib-111 enrolled in Phase 1 and 501 enrolled in Phase 2. The Phase 1 component of the study was conducted at 8 study sites in the US, Australia, and France. Phase 2 was conducted at 49 study sites in the US, France, Poland, and Australia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Rociletinib <900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID).'}, {'id': 'BG001', 'title': 'Rociletinib 900 mg BID FB Capsules', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID).'}, {'id': 'BG002', 'title': 'Rociletinib 500 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID).'}, {'id': 'BG003', 'title': 'Rociletinib 625 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID).'}, {'id': 'BG004', 'title': 'Rociletinib 750 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID).'}, {'id': 'BG005', 'title': 'Rociletinib 1000 mg BID HBr Tablets', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID).'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '60.1', 'spread': '11.54', 'groupId': 'BG000'}, {'value': '58.9', 'spread': '8.37', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '11.45', 'groupId': 'BG002'}, {'value': '62.5', 'spread': '11.14', 'groupId': 'BG003'}, {'value': '61.5', 'spread': '11.82', 'groupId': 'BG004'}, {'value': '65.2', 'spread': '5.53', 'groupId': 'BG005'}, {'value': '62.5', 'spread': '11.29', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '424', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '188', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '495', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '92', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '124', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '368', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '94', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '368', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '124', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '103', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time Since Diagnosis of NSCLC (months)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '611', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '40.4', 'spread': '29.2', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '31.94', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '25.81', 'groupId': 'BG002'}, {'value': '36.7', 'spread': '31.41', 'groupId': 'BG003'}, {'value': '37.6', 'spread': '29.97', 'groupId': 'BG004'}, {'value': '47.4', 'spread': '27.03', 'groupId': 'BG005'}, {'value': '37.4', 'spread': '29.17', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data not available for one participant in the 500 mg BID Hbr treatment group.'}, {'title': 'T790M Status ( Determined by Central Lab)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '49', 'groupId': 'BG006'}]}, {'title': 'Positive', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '480', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of CNS Metastases', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '267', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Previous Therapies', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.65', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '1.66', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.74', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '1.91', 'groupId': 'BG003'}, {'value': '2.9', 'spread': '2.11', 'groupId': 'BG004'}, {'value': '3.8', 'spread': '2.04', 'groupId': 'BG005'}, {'value': '2.9', 'spread': '1.88', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Therapies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Previous TKI Therapies', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '612', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '1.48', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '0.87', 'groupId': 'BG002'}, {'value': '1.6', 'spread': '0.77', 'groupId': 'BG003'}, {'value': '1.6', 'spread': '0.86', 'groupId': 'BG004'}, {'value': '1.8', 'spread': '0.75', 'groupId': 'BG005'}, {'value': '1.6', 'spread': '0.86', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Therapies', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-12', 'size': 501680, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-10T13:48', 'hasProtocol': False}, {'date': '2016-08-03', 'size': 3006839, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-11T13:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2012-01-31', 'resultsFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-17', 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of T790M Positive Patients With Confirmed Response Per Investigator', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 42 months', 'description': 'Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.'}, {'measure': 'Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 36 months', 'description': 'Duration of Response in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.'}, {'measure': 'Dose Limiting Toxicity (DLT) Incidence', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 21', 'description': 'The number of Phase 1 patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) Determined by Investigator Assessment', 'timeFrame': 'Cycle 1 Day 1 to date of death, assessed up to 42 months', 'description': 'Overall survival was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.'}, {'measure': 'Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment, up to approximately 42 months', 'description': 'Progression-free survival was calculated as the number of days from the date of the first dose of study drug to the date of disease progression or death due to any cause + 1. Patients without a documented event of disease progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments have been performed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.'}, {'measure': 'PK Profile of Rociletinib - Cmax', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'Cmax = maximum concentration following administration of rociletinib'}, {'measure': 'PK Profile of Rociletinib - Tmax', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'Tmax = time to maximum concentration following administration of rociletinib'}, {'measure': 'PK Profile of Rociletinib - AUC 0-24', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'AUC 0-24 = area under the curve from 0 to 24 hours'}, {'measure': 'PK Profile of Rociletinib - T 1/2', 'timeFrame': 'Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days', 'description': 'T 1/2 = elimination half-life following administration of rociletinib'}, {'measure': 'Food Effect on PK of Rociletinib - Cmax', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'Cmax = maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.'}, {'measure': 'Food Effect on PK of Rociletinib - Tmax', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'Tmax = time to maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.'}, {'measure': 'Food Effect on PK of Rociletinib - AUC 0-24', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'AUC 0-24 = area under the curve from 0 to 24 hours. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.'}, {'measure': 'Food Effect on PK of Rociletinib - C24', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'C24 = rociletinib plasma concentration at 24 hours post the morning dose. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.'}, {'measure': 'Food Effect on PK of Rociletinib - T 1/2', 'timeFrame': 'Day -7 prior to Cycle 1 Day 1, or approximately 7 days', 'description': 'T 1/2 = elimination half-life following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.'}, {'measure': 'QTcF Values Post Baseline by Daily Dose', 'timeFrame': 'Screening to End of Treatment, up to approximately 42 months', 'description': "Frequency of QT interval prolongation by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient."}, {'measure': 'QTcF Value Change From Baseline', 'timeFrame': 'Screening to End of Treatment, up to approximately 42 months', 'description': "QTcF value change from baseline by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient."}, {'measure': 'Objective Response Rate (ORR), Duration of Response (DOR) and Progression-Free Survival (PFS) Per RECIST Version 1.1 as Determined by IRR', 'timeFrame': 'Cycle 1 Day 1 to End of Treatment / End of Follow-up', 'description': 'Objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) per RECIST Version 1.1 as determined by independent radiology review (IRR)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'metastatic', 'locally advanced', 'lung', 'non-small cell lung cancer', 'NSCLC', 'epidermal growth factor receptor', 'EGFR', 'T790M', 'CO-1686', 'unresectable', 'recurrent', 'EGFR-directed therapy', 'irreversible EGFR inhibitor', 'TIGER', 'Rociletinib'], 'conditions': ['Locally Advanced or Metastatic Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '29216356', 'type': 'DERIVED', 'citation': 'Krug AK, Enderle D, Karlovich C, Priewasser T, Bentink S, Spiel A, Brinkmann K, Emenegger J, Grimm DG, Castellanos-Rizaldos E, Goldman JW, Sequist LV, Soria JC, Camidge DR, Gadgeel SM, Wakelee HA, Raponi M, Noerholm M, Skog J. Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma. Ann Oncol. 2018 Mar 1;29(3):700-706. doi: 10.1093/annonc/mdx765.'}, {'pmid': '25923550', 'type': 'DERIVED', 'citation': 'Sequist LV, Soria JC, Goldman JW, Wakelee HA, Gadgeel SM, Varga A, Papadimitrakopoulou V, Solomon BJ, Oxnard GR, Dziadziuszko R, Aisner DL, Doebele RC, Galasso C, Garon EB, Heist RS, Logan J, Neal JW, Mendenhall MA, Nichols S, Piotrowska Z, Wozniak AJ, Raponi M, Karlovich CA, Jaw-Tsai S, Isaacson J, Despain D, Matheny SL, Rolfe L, Allen AR, Camidge DR. Rociletinib in EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1700-9. doi: 10.1056/NEJMoa1413654.'}]}, 'descriptionModule': {'briefSummary': 'Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.', 'detailedDescription': 'Lung cancer remains the most common cancer worldwide with non-small cell lung cancer accounting for 85% of cases. Cytotoxic chemotherapy has been the mainstay of patients with NSCLC; however, survival rates remain low and toxicity is significant. Molecularly targeted therapies have proven to be superior to chemotherapy for NSCLC patients whose tumors have mutations in EGFR. Recent studies have established tyrosine kinase inhibitors (TKIs) as the gold standard for treating EGFR-mutation-positive NCSLC. However, patients on TKIs eventually progress, and in approximately 50% of cases, progression is due to development of an additional mutation called T790M. There are currently no approved therapies for patients who progress on TKIs. Rociletinib may provide an effective therapy for a patient population with few alternative treatment options. Nonclinical data demonstrate that rociletinib inhibits T790M. It is anticipated that rociletinib may promote cell death in tumor cells with the T790M mutation, thus providing possible therapeutic benefit in patients who have developed T790M-mediated resistance to first generation TKIs.\n\nThis is a two-part, open-label study of oral rociletinib administered daily in previously treated NSCLC patients who have documented evidence of an activating mutation in the EGFR gene and have failed treatment with an EGFR inhibitor such as erlotinib, gefitinib or afatinib.\n\nThis study will include 2 parts:\n\nPhase 1: Dose-escalation Period with 21-day cycles; optional Treatment Extension Period starting on Day 22\n\nPhase 2: Evaluation of activity and safety in patients with the T790M EGFR mutation who have:\n\nCohort A - Progressed on EGFR directed therapy (irrespective of the number and order of previous lines of NSCLC therapy) or Cohort B - Progression on the first single agent EGFR directed therapy received and also had no more than one previous line of chemotherapy or Cohort C - Patients with discordance between local (T790M positive) and central (T790M negative) T790M results, or had no central test result due to inadequacy of the tissue specimen and known to be T790M positive by local test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria -\n\nAll patients must meet the following inclusion criteria:\n\n1. Metastatic or unresectable locally advanced NSCLC\n2. Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion\n3. Biopsy of either primary or metastatic tumor tissue within 60 days of dosing\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n5. Minimum age of 18 years\n6. Adequate hematological and biological function\n7. Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation\n\nPhase 2 Cohorts must also meet the following inclusion criteria:\n\n* Disease progression confirmed by radiologic assessment while on treatment with EGFR- TKI Or\n* Disease progression confirmed by radiologic assessment while on treatment with the first single agent EGFR TKI and\n* Documented evidence of T790M mutation in EGFR following disease progression on the first single agent EGFR TKI.\n* Measureable disease according to RECIST Version 1.1\n\nExclusion Criteria -\n\nAny of the following criteria will exclude patients from study participation:\n\n1. Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene\n2. Active second malignancy\n3. Known pre-existing interstitial lung disease\n4. Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).\n5. Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib\n6. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib\n7. Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR\n8. Certain cardiac abnormalities or history\n9. Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib\n10. Females who are pregnant or breastfeeding\n11. Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib\n12. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study\n13. Any other reason the investigator considers the patient should not participate in the study'}, 'identificationModule': {'nctId': 'NCT01526928', 'briefTitle': 'Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clovis Oncology, Inc.'}, 'officialTitle': 'A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'CO-1686-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rociletinib <900 mg BID FB formulation', 'description': 'Rociletinib free base (FB) dose \\<900 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rociletinib 900 mg BID FB formulation', 'description': 'Rociletinib free base (FB) dose 900 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rociletinib 500 mg BID HBr formulation', 'description': 'Rociletinib hydrobromide (HBr) dose 500 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rociletinib 625 mg BID HBr formulation', 'description': 'Rociletinib hydrobromide (HBr) dose 625 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rociletinib 750 mg BID HBr formulation', 'description': 'Rociletinib hydrobromide (HBr) dose 750 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}, {'type': 'EXPERIMENTAL', 'label': 'Rociletinib 1000 mg BID HBr formulation', 'description': 'Rociletinib hydrobromide (HBr) dose 1000 mg twice a day (BID)', 'interventionNames': ['Drug: Rociletinib']}], 'interventions': [{'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib \\<900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles', 'armGroupLabels': ['Rociletinib <900 mg BID FB formulation']}, {'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib 900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles', 'armGroupLabels': ['Rociletinib 900 mg BID FB formulation']}, {'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib 500 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles\n\nPhase 2: Rociletinib 500 mg BID HBr will be administered daily', 'armGroupLabels': ['Rociletinib 500 mg BID HBr formulation']}, {'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib 625 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles\n\nPhase 2: Rociletinib 625 mg BID HBr will be administered daily', 'armGroupLabels': ['Rociletinib 625 mg BID HBr formulation']}, {'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib 750 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles\n\nPhase 2: Rociletinib 750 mg BID HBr will be administered daily', 'armGroupLabels': ['Rociletinib 750 mg BID HBr formulation']}, {'name': 'Rociletinib', 'type': 'DRUG', 'otherNames': ['CO-1686'], 'description': 'Phase 1: Rociletinib 1000 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles\n\nPhase 2: Rociletinib 1000 mg BID HBr will be administered daily', 'armGroupLabels': ['Rociletinib 1000 mg BID HBr formulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Samuel Oschin Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 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'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106-0995', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Saint Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Care Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Regional Cancer Care Associates', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '07834', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Regional Cancer Center', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Monter Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43202', 'city': 'Columbus', 'state': 'Ohio', 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'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Med University Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clovis Oncology, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}