Viewing Study NCT01004861

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Ignite Creation Date: 2025-12-24 @ 11:55 AM
Ignite Modification Date: 2025-12-31 @ 12:59 PM
Study NCT ID: NCT01004861
Status: COMPLETED
Last Update Posted: 2022-01-04
First Post: 2009-10-28
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety Study of PLX108-01 in Patients With Solid Tumors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600259', 'term': 'pexidartinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTRinfo@dsi.com', 'phone': '908-992-6400', 'title': 'Medical Director', 'organization': 'Daiichi Sankyo Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (and serious adverse events) were recorded from the time the participant received the first dose of study drug up to 30 days after the last dose, up to approximately 30 months postdose.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced or recurrent mucoepidermoid carcinoma (MEC) who received PLX3397.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG010', 'title': 'ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG012', 'title': 'Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with other solid tumor types who received PLX3397.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 36}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 28}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 26}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 7}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 9}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 10}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 13}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 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{'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'OG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'OG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'OG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'OG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'OG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'OG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}, {'id': 'OG007', 'title': 'All Participants', 'description': 'All participants with advanced, incurable, solid tumors who received PL3397.'}], 'classes': [{'title': 'Censored participants', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}, {'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall tumor response was assessed in the Efficacy Evaluable Population.'}, {'type': 'PRIMARY', 'title': 'Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension (Efficacy Evaluable Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Extension: MEC Cohort', 'description': 'Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.'}, {'id': 'OG001', 'title': 'Dose Extension: PVNS Cohort', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}, {'id': 'OG002', 'title': 'Dose Extension: GIST Cohort', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.'}, {'id': 'OG003', 'title': 'Dose Extension: ATC Cohort', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.'}, {'id': 'OG004', 'title': 'Dose Extension: Malignant Effusion Cohort', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.'}, {'id': 'OG005', 'title': 'Dose Extension: Other Solid Tumor Type Cohort', 'description': 'Participants with other solid tumor types who received PLX3397.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Overall response rate (CR or PR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall tumor response was assessed in the Efficacy Evaluable Population.'}, {'type': 'PRIMARY', 'title': 'Duration of Response (Efficacy Evaluable Population) - Dose Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Extension: MEC Cohort', 'description': 'Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.'}, {'id': 'OG001', 'title': 'Dose Extension: PVNS Cohort', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}, {'id': 'OG002', 'title': 'Dose Extension: GIST Cohort', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIS) who received PLX3397.'}, {'id': 'OG003', 'title': 'Dose Extension: ATC Cohort', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.'}, {'id': 'OG004', 'title': 'Dose Extension: Malignant Effusion Cohort', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.'}, {'id': 'OG005', 'title': 'Dose Extension: Other Solid Tumor Type Cohort', 'description': 'Participants with other solid tumor types who received PLX3397.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lack of median value is due to \\<50% of the participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.', 'groupId': 'OG001', 'lowerLimit': '943', 'upperLimit': 'NA'}, {'value': '115', 'comment': 'There were not enough events to estimate a 95% confidence interval for the median survival time.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From initial response until disease progression or death, up to approximately 30 months postdose', 'description': 'Duration of Response (DOR) is defined as the number of days from the date of initial response (CR or PR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, DOR is censored as of the date of their last imaging exam of target or non-target lesions prior to post-surgery and/or off-treatment scans.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of response was assessed among participants with response of CR or PR in the Efficacy Evaluable Population.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (Efficacy Evaluable Population) - Dose Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Extension: MEC Cohort', 'description': 'Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.'}, {'id': 'OG001', 'title': 'Dose Extension: PVNS Cohort', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}, {'id': 'OG002', 'title': 'Dose Extension: GIST Cohort', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.'}, {'id': 'OG003', 'title': 'Dose Extension: ATC Cohort', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.'}, {'id': 'OG004', 'title': 'Dose Extension: Malignant Effusion Cohort', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.'}, {'id': 'OG005', 'title': 'Dose Extension: Other Solid Tumor Type Cohort', 'description': 'Participants with other solid tumor types who received PLX3397.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of events; Lack of median value is due to 50% or fewer participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of events; Lack of median value is due to 50% or fewer participants experiencing the event. In a Kaplan-Meier analysis, the curve would never fall below the 50% mark, and would continue to the largest observed censored time value.', 'groupId': 'OG001', 'lowerLimit': '667', 'upperLimit': 'NA'}, {'value': '54', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '164'}, {'value': '50', 'groupId': 'OG003', 'lowerLimit': '34', 'upperLimit': '56'}, {'value': '78', 'comment': 'Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.', 'groupId': 'OG004', 'lowerLimit': '51', 'upperLimit': 'NA'}, {'value': '161', 'groupId': 'OG005', 'lowerLimit': '54', 'upperLimit': '504'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Cycle 1 Day 1 to disease progression or death', 'description': 'Progression-Free Survival (PFS) is defined as the number of days from the first day of treatment to the first documented disease progression or date of death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, PFS is censored at the date of last evaluable tumor assessment.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Progression-free survival was assessed in the Efficacy Evaluable Population.'}, {'type': 'PRIMARY', 'title': 'Best Overall Tumor Response (PVNS Cohort) Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PVNS Cohort', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'NE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Overall response rate (CR or PR)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Best overall tumor response was assessed in the Efficacy Evaluable Population.'}, {'type': 'PRIMARY', 'title': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Cmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'OG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'OG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'OG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'OG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'OG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'OG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1730', 'groupId': 'OG000', 'lowerLimit': '1460', 'upperLimit': '2900'}, {'value': '3630', 'groupId': 'OG001', 'lowerLimit': '1360', 'upperLimit': '5300'}, {'value': '3160', 'groupId': 'OG002', 'lowerLimit': '2140', 'upperLimit': '5210'}, {'value': '6570', 'groupId': 'OG003', 'lowerLimit': '4000', 'upperLimit': '14300'}, {'value': '6290', 'groupId': 'OG004', 'lowerLimit': '5520', 'upperLimit': '10400'}, {'value': '10600', 'groupId': 'OG005', 'lowerLimit': '5070', 'upperLimit': '12500'}, {'value': '6320', 'groupId': 'OG006', 'lowerLimit': '5920', 'upperLimit': '10100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 15', 'description': 'Cycle 1 Day 15 pharmacokinetic (PK) timepoints taken are: For once daily (QD) dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For twice a day (BID) dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Tmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'OG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'OG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'OG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'OG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'OG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'OG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '4.00'}, {'value': '1.97', 'groupId': 'OG001', 'lowerLimit': '0.58', 'upperLimit': '2.03'}, {'value': '0.98', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '2.20'}, {'value': '1.04', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '2.03'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '2.03'}, {'value': '1.05', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '4.17'}, {'value': '2.03', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '6.95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 15', 'description': 'Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Area Under the Curve (AUC0-24), Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'OG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'OG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'OG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'OG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'OG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'OG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '26200', 'groupId': 'OG000', 'lowerLimit': '13200', 'upperLimit': '37100'}, {'value': '50400', 'groupId': 'OG001', 'lowerLimit': '19500', 'upperLimit': '83100'}, {'value': '40500', 'groupId': 'OG002', 'lowerLimit': '29500', 'upperLimit': '57300'}, {'value': '81000', 'groupId': 'OG003', 'lowerLimit': '74300', 'upperLimit': '166000'}, {'value': '107000', 'groupId': 'OG004', 'lowerLimit': '68400', 'upperLimit': '139000'}, {'value': '173000', 'groupId': 'OG005', 'lowerLimit': '80200', 'upperLimit': '190000'}, {'value': '115000', 'groupId': 'OG006', 'lowerLimit': '105000', 'upperLimit': '226000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Day 15 (QD dosing: predose [morning] and 0.5, 1, 2, 4, and 8 hours postdose; BID dosing: predose [morning] and 1, 2, 4, and 7 hours postdose)', 'description': 'Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing, predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.'}, {'type': 'PRIMARY', 'title': 'Numeric Rating Scale (NRS) for PVNS Symptoms Sum of Scores Through Cycle 2 (Efficacy Evaluable Population) - Dose Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NRS for PVNS Symptoms Evaluable Population', 'description': 'Participants who were administered the NRS scale at baseline and monthly on treatment.'}], 'classes': [{'title': 'Pain; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Pain; Cycle 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Swelling; Cycle 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Stiffness; Cycle 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Instability; Cycle 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Limited motion; Cycle 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Limited Motion; Cycle 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 15, Cycle 2, Cycle 3, Cycle 12, Cycle 24, Cycle 36, and Cycle 46 (each cycle was 28 days)', 'description': 'The NRS for PVNS Symptoms instrument is a 5-item self-administered questionnaire to assess the "worst" of each of the symptoms pain, swelling, stiffness, instability and limited motion in the last 24 hours. A 0 to 10 NRS is provided for each symptom. For pain, 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". For the other 4 symptoms, 0 indicates "no (symptom)" and 10 indicates "(symptom) worst imaginable", e.g., "swelling - worst imaginable." Higher scores indicated worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'NRS for PVNS symptoms were assessed in patients with available data in the Efficacy Evaluable Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'FG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'FG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'FG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'FG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'FG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'FG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}, {'id': 'FG007', 'title': 'Dose Extension: MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced or recurrent mucoepidermoid carcinoma (MEC) who received PLX3397.'}, {'id': 'FG008', 'title': 'Dose Extension: PVNS Cohort PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}, {'id': 'FG009', 'title': 'Dose Extension: GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.'}, {'id': 'FG010', 'title': 'Dose Extension: ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.'}, {'id': 'FG011', 'title': 'Dose Extension: Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.'}, {'id': 'FG012', 'title': 'Dose Extension: Other Tumors 1000 mg/Day (600mg AM, 400mg PM)', 'description': 'Participants with other solid tumor types who received PLX3397.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '39'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '20'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '39'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '9'}, {'groupId': 'FG011', 'numSubjects': '8'}, {'groupId': 'FG012', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '13'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'Transitioned to Phase 4 study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Patient completed 12-week follow-up and continued on commercially approved drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Patient withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Surgical resection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Patient maintained complete response status throughout drug holiday', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Study termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The dose escalation phase administered ascending daily oral doses of PLX3397 to patients with solid tumors and evaluated PK and toxicity. Once the recommended phase 2 dose was reached, 6 extension cohorts were enrolled, consisting of a variety of tumor types.', 'preAssignmentDetails': 'At least 3 participants and up to 6 participants were to be enrolled in each dose level using 100% dose increments for each level in the absence of Grade 2 or greater drug-attributable toxicity. Dose escalation was only permitted if adequate safety and tolerability were observed at the previous lower dose for 28 days for the first 3 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '20', 'groupId': 'BG012'}, {'value': '132', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Escalation Cohort 1: 200 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.'}, {'id': 'BG001', 'title': 'Dose Escalation Cohort 2: 300 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.'}, {'id': 'BG002', 'title': 'Dose Escalation Cohort 3: 400 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.'}, {'id': 'BG003', 'title': 'Dose Escalation Cohort 4: 600 mg QD', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.'}, {'id': 'BG004', 'title': 'Dose Escalation Cohort 5: 900 mg/Day', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.'}, {'id': 'BG005', 'title': 'Dose Escalation Cohort 6: 1200 mg/Day', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.'}, {'id': 'BG006', 'title': 'Dose Escalation Cohort 7: 1000 mg/Day', 'description': 'Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.'}, {'id': 'BG007', 'title': 'Dose Extension: MEC Cohort', 'description': 'Participants with advanced mucoepidermoid carcinoma (MEC) who received PLX3397.'}, {'id': 'BG008', 'title': 'Dose Extension: PVNS Cohort', 'description': 'Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.'}, {'id': 'BG009', 'title': 'Dose Extension: GIST Cohort', 'description': 'Participants with advanced gastrointestinal stromal tumor (GIS) who received PLX3397.'}, {'id': 'BG010', 'title': 'Dose Extension: ATC Cohort', 'description': 'Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.'}, {'id': 'BG011', 'title': 'Dose Extension: Malignant Effusion Cohort', 'description': 'Participants with advanced solid tumors with malignant effusion who received PLX3397.'}, {'id': 'BG012', 'title': 'Dose Extension: Other Solid Tumor Type Cohort', 'description': 'Participants with other solid tumor types who received PLX3397.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '93', 'groupId': 'BG013'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '39', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '61.5', 'spread': '19.1', 'groupId': 'BG003'}, {'value': '52.3', 'spread': '15.0', 'groupId': 'BG004'}, {'value': '56.3', 'spread': '17.1', 'groupId': 'BG005'}, {'value': '50.4', 'spread': '19.8', 'groupId': 'BG006'}, {'value': '47.3', 'spread': '18.4', 'groupId': 'BG007'}, {'value': '45.1', 'spread': '14.0', 'groupId': 'BG008'}, {'value': '57.6', 'spread': '12.1', 'groupId': 'BG009'}, {'value': '65.9', 'spread': '14.7', 'groupId': 'BG010'}, {'value': '58.1', 'spread': '13.3', 'groupId': 'BG011'}, {'value': '52.0', 'spread': '15.1', 'groupId': 'BG012'}, {'value': '58.3', 'spread': '14.9', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '68', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '15', 'groupId': 'BG012'}, {'value': '64', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '18', 'groupId': 'BG012'}, {'value': '121', 'groupId': 'BG013'}]}]}, {'title': 'Black of African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}]}, {'title': 'Multiple races', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '20', 'groupId': 'BG012'}, {'value': '41', 'groupId': 'BG013'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-25', 'size': 1986738, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-30T08:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-06', 'studyFirstSubmitDate': '2009-10-28', 'resultsFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2009-10-28', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-23', 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Escalation (Efficacy Evaluable Population)', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Summary of Derived Best Tumor Response Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension (Efficacy Evaluable Population)', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression (up to approximately 30 months postdose)', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Duration of Response (Efficacy Evaluable Population) - Dose Extension', 'timeFrame': 'From initial response until disease progression or death, up to approximately 30 months postdose', 'description': 'Duration of Response (DOR) is defined as the number of days from the date of initial response (CR or PR confirmed at least 28 days later) to the date of first documented disease progression/relapse or death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, DOR is censored as of the date of their last imaging exam of target or non-target lesions prior to post-surgery and/or off-treatment scans.'}, {'measure': 'Progression-free Survival (Efficacy Evaluable Population) - Dose Extension', 'timeFrame': 'From Cycle 1 Day 1 to disease progression or death', 'description': 'Progression-Free Survival (PFS) is defined as the number of days from the first day of treatment to the first documented disease progression or date of death, whichever occurs first. If no disease progression or death is documented prior to study termination, analysis cutoff, or the start of confounding anticancer therapy, PFS is censored at the date of last evaluable tumor assessment.'}, {'measure': 'Best Overall Tumor Response (PVNS Cohort) Per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 - Dose Extension', 'timeFrame': 'Every 2 months beginning Cycle 3, Day 1 until disease progression', 'description': 'Best overall tumor response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) is reported, including participants who were not evaluable (NE).\n\nRECIST v1.1 for target lesions are assessed by magnetic resonance imaging, computed tomography, or positron emission tomography-computed tomography and are summarized as: CR, Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \\<10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; PD, at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). In addition, the sum must also demonstrate an absolute increase of at least 5 mm; SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.'}, {'measure': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Cmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'timeFrame': 'Cycle 1, Day 15', 'description': 'Cycle 1 Day 15 pharmacokinetic (PK) timepoints taken are: For once daily (QD) dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For twice a day (BID) dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.'}, {'measure': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Tmax, Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'timeFrame': 'Cycle 1, Day 15', 'description': 'Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.'}, {'measure': 'Summary Statistics for Selected PLX3397 Pharmacokinetics Parameter Area Under the Curve (AUC0-24), Study Day Cycle 1 Day 15, Stratified by Cohort - Dose Escalation', 'timeFrame': 'Cycle 1, Day 15 (QD dosing: predose [morning] and 0.5, 1, 2, 4, and 8 hours postdose; BID dosing: predose [morning] and 1, 2, 4, and 7 hours postdose)', 'description': 'Cycle 1 Day 15 PK timepoints taken are: For QD dosing, obtained predose (morning) and 0.5, 1, 2, 4, and 8 hours postdose. For BID dosing, predose (morning) and 1, 2, 4, and 7 hours postdose. The second dose will then be administered, and PK obtained 1 hour post the second dose (8 hours post the first dose). For BID dosing, no run-in is planned.'}, {'measure': 'Numeric Rating Scale (NRS) for PVNS Symptoms Sum of Scores Through Cycle 2 (Efficacy Evaluable Population) - Dose Extension', 'timeFrame': 'Baseline, Cycle 1 Day 15, Cycle 2, Cycle 3, Cycle 12, Cycle 24, Cycle 36, and Cycle 46 (each cycle was 28 days)', 'description': 'The NRS for PVNS Symptoms instrument is a 5-item self-administered questionnaire to assess the "worst" of each of the symptoms pain, swelling, stiffness, instability and limited motion in the last 24 hours. A 0 to 10 NRS is provided for each symptom. For pain, 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine". For the other 4 symptoms, 0 indicates "no (symptom)" and 10 indicates "(symptom) worst imaginable", e.g., "swelling - worst imaginable." Higher scores indicated worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PVNS'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '34716196', 'type': 'DERIVED', 'citation': 'Tap WD, Singh AS, Anthony SP, Sterba M, Zhang C, Healey JH, Chmielowski B, Cohn AL, Shapiro GI, Keedy VL, Wainberg ZA, Puzanov I, Cote GM, Wagner AJ, Braiteh F, Sherman E, Hsu HH, Peterfy C, Gelhorn HL, Ye X, Severson P, West BL, Lin PS, Tong-Starksen S. Results from Phase I Extension Study Assessing Pexidartinib Treatment in Six Cohorts with Solid Tumors including TGCT, and Abnormal CSF1 Transcripts in TGCT. Clin Cancer Res. 2022 Jan 15;28(2):298-307. doi: 10.1158/1078-0432.CCR-21-2007. Epub 2021 Oct 29.'}, {'pmid': '33289960', 'type': 'DERIVED', 'citation': 'Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.'}, {'pmid': '26222558', 'type': 'DERIVED', 'citation': 'Tap WD, Wainberg ZA, Anthony SP, Ibrahim PN, Zhang C, Healey JH, Chmielowski B, Staddon AP, Cohn AL, Shapiro GI, Keedy VL, Singh AS, Puzanov I, Kwak EL, Wagner AJ, Von Hoff DD, Weiss GJ, Ramanathan RK, Zhang J, Habets G, Zhang Y, Burton EA, Visor G, Sanftner L, Severson P, Nguyen H, Kim MJ, Marimuthu A, Tsang G, Shellooe R, Gee C, West BL, Hirth P, Nolop K, van de Rijn M, Hsu HH, Peterfy C, Lin PS, Tong-Starksen S, Bollag G. Structure-Guided Blockade of CSF1R Kinase in Tenosynovial Giant-Cell Tumor. N Engl J Med. 2015 Jul 30;373(5):428-37. doi: 10.1056/NEJMoa1411366.'}]}, 'descriptionModule': {'briefSummary': 'PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and older\n* Solid tumors refractory to standard therapy\n* For the Extension cohorts, patients must have measurable disease by RECIST criteria and meet the following disease-specific criteria:\n\n * For advanced or recurrent mucoepidermal carcinoma (MEC) of the salivary gland, patients must not be candidates for curative surgery or radiotherapy.\n * For pigmented villo-nodular synovitis (PVNS), patients must have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS, or resectable tumor requesting mutilating surgery, as well as demonstrated progressive disease in the last 12 months.\n * For gastrointestinal stromal tumors (GIST), patients must have failed previous therapy with imatinib and sunitinib. Patients with known PDGFR mutations are excluded, but mutation testing is not required for study entry.\n * For anaplastic thyroid cancer (ATC), patients must have histologically or cytologically diagnosed advanced ATC.\n * For metastatic solid tumors with documented malignant pleural and/or peritoneal effusions, patients must not be receiving specific therapy for the effusion or have an indwelling drain.\n* Eastern Cooperative Oncology Group performance status 0 or 1\n* Life expectancy \\>= 3 months\n* Adequate hepatic, renal, and bone marrow function\n\nExclusion Criteria:\n\n* Specific anti-cancer therapy within 3 weeks of study start\n* Uncontrolled intercurrent illness\n* Refractory nausea or vomiting, or malabsorption\n* Mean corrected QT interval (QTc) \\>= 450 msec (for males) or QTc \\>= 470 msec (for females)'}, 'identificationModule': {'nctId': 'NCT01004861', 'briefTitle': 'Safety Study of PLX108-01 in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX3397 in Patients With Advanced, Incurable, Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology', 'orgStudyIdInfo': {'id': 'PLX108-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLX3397', 'interventionNames': ['Drug: PLX3397']}], 'interventions': [{'name': 'PLX3397', 'type': 'DRUG', 'description': 'Capsules administered once or twice daily, continuous dosing', 'armGroupLabels': ['PLX3397']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center (MSKCC)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Oncology Hematology Associates', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, PA (North)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '99218', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hematology & Oncology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Plexxikon', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}