Viewing Study NCT02315534

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Ignite Creation Date: 2025-12-25 @ 2:27 AM
Ignite Modification Date: 2026-02-17 @ 10:40 PM
Study NCT ID: NCT02315534
Status: COMPLETED
Last Update Posted: 2023-11-15
First Post: 2014-12-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621033', 'term': 'napabucasin'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmarshall@bostonbiomedical.com', 'phone': '843-364-8039', 'title': 'Connor Marshall', 'organization': 'Sumitomo Dainippon Pharma Oncology'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Every 1-2 weeks from study enrollment until end of treatment. Following last dose, follow-up period of 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Participants whom surgery was recommended and received at least one dose of study medication (BBI608).', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Patients who were not candidates for surgical resection and received at least one dose of study medication (BBI608).', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'deathsNumAffected': 22, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyramidal tract syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemianopia homonymous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyramidal tract syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Recommended.', 'description': 'The first 6 patients whom surgery was recommended that received 28 days of continuous daily administration of BBI608 in combination with TMZ. Patients also had to be ≥ 80% compliant to assigned dose to qualify for DLT analysis.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'The first 6 patients whom surgery was not recommended that received 28 days of continuous daily administration of BBI608 in combination with TMZ. Patients also had to be ≥ 80% compliant to assigned dose to qualify for DLT analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days after first administration of combination treatment (BBI608+TMZ)', 'description': 'Number of patients who experienced a dose limiting toxicity following a dosing of BBI608', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Up to the first 6 patients whom surgery was and wasn't recommended that received 28 days of continuous daily administration of BBI608 in combination with TMZ. Patients also had to be≥ 80% compliant to assigned dose to qualify for DLT analysis."}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended.', 'description': 'Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended.', 'description': 'Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.07', 'groupId': 'OG000', 'lowerLimit': '16.81', 'upperLimit': '40.45'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of exposure to study drug to first objective documentation of disease progression or death due to any cause, assessed up to 6 months', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) therapy defined as the percentage of patients who have survived without objective disease progression for at least 6 months after treatment per neuro-oncology (RANO) criteria who had evaluable disease at baseline. PFS-6 is defined as the percentage of patients who survived without objective disease progression per RANO criteria for at least 6 months after treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.84', 'groupId': 'OG000', 'lowerLimit': '7.84', 'upperLimit': '28.75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the time of exposure to study drug to first objective documentation of disease progression or death due to any cause, up to 12 months', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) therapy defined as the percentage of patients who have survived without objective disease progression for at least 12 months after treatment per neuro-oncology (RANO) criteria who had evaluable disease at baseline. PFS-12 is defined as the percentage of patients who survived without objective disease progression per RANO criteria for at least 12 months after treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.05', 'groupId': 'OG000', 'lowerLimit': '6.01', 'upperLimit': '10.87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of exposure to study drug to death from any cause. If patient discontinued study drug, they were assessed the first 3 months after discontinuation, then every 3 months up to 1 year, then every 6 months thereafter until death.', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) on the overall survival of patients with recurrent or progressive glioblastoma multiforme (GBM) who had not received prior treatment with bevacizumab or other anti-vascular endothelial growth factor agents who either were eligible or not eligible for surgical resection.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '49.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'To assess the percentage of patients that had evaluable disease at baseline with a documented complete response, partial response, and stable disease (CR + PR + SD) based on the Response Assessment in Neuro-Oncology (RANO) criteria out of all patients who received at least one dose of any study drug and had evaluable disease at baseline.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Participants who were not recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Participants who were recommended for surgery that had evaluable disease at baseline and received at least 28 days of study drug (BBI608) in combination with temozolomide (TMZ). Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '10.87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The proportion of patients with a documented complete response and partial response (CR + PR) based on RANO criteria.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was only collected and analyzed for arms that enrolled at least 10 evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Profile of BBI608 and Temozolomide When Administered in Combination With Temozolomide as Assessed by the Area Under the Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Candidates whom surgery is recommended that received at least one dose of study drug and had at least one quantifiable concentration'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Candidates for whom surgery was not recommended that received at least one dose of study drug and had at least one quantifiable concentration'}], 'classes': [{'categories': [{'measurements': [{'value': '4820', 'spread': '19', 'groupId': 'OG000'}, {'value': '4200', 'spread': '37.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 and Day 5 after the first dosing, prior to dosing and 1, 2, 3, 5, 5h40m (day 1 only), 6, 7, 8 and 24 hours after first dose of BBI608', 'description': 'The area under the curve of BBI608, from time 0 to the last quantifiable concentration, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)', 'unitOfMeasure': 'h*ng/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Candidates for who surgery was and was not recommended that received at least one dose of study drug and had at least one quantifiable concentration.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic Activity of BBI608 When Administered in Combination With Temozolomide as Assessed by Tumor Biopsy and Cancer Stem Cell Assays as Well as the Concentration of Study Drug in Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Candidates whom surgery is either recommended or not recommended that received 28 days of study drug and provided tissue samples'}, {'id': 'OG001', 'title': 'Candidates Whom Surgery is Recommended', 'description': 'Candidates whom surgery is either recommended or not recommended that received 28 days of study drug and provided tissue samples'}], 'classes': [{'categories': [{'title': 'pSTAT3+', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'pSTAT3-', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of surgical resection', 'description': 'Tumor samples to provide information of the biomarkers by histopathology and Cancer Stem Cell assays as well as the concentration of study drug in tumors.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Candidates whom surgery is either recommended or nor recommended that received 28 days of study drug and provided tissue samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Candidates Whom Surgery is Recommended.', 'description': 'BBI608 will be administered at the recommended phase 2 dose (RP2D) twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide'}, {'id': 'FG001', 'title': 'Candidates Whom Surgery is Not Recommended.', 'description': 'Patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the recommended phase 2 dose (RP2D) in combination with temozolomide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Assessment of Dose-limiting Toxicity (DLT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Off Treatment Due to Radiologic Disease Progression (PD)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Off Treatment Due to Clinically Unacceptable Toxicities', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Off Treatment Due to Patient Request', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Off Treatment Due to Clinical PD', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'There are no pre-assignment details, study arm was determined at patient enrollment to the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Candidates Whom Surgery is Recommended.', 'description': 'Candidates who were candidates for repeat surgical resection'}, {'id': 'BG001', 'title': 'Candidates Whom Surgery is Not Recommended', 'description': 'Candidates who were not candidates for repeat surgical resection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '15.54', 'groupId': 'BG001'}, {'value': '55.1', 'spread': '14.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'title': 'Lifetime nonsmoker', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '100.55', 'spread': '26.345', 'groupId': 'BG000'}, {'value': '78.21', 'spread': '16.170', 'groupId': 'BG001'}, {'value': '80.84', 'spread': '13.608', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '177.25', 'spread': '7.411', 'groupId': 'BG000'}, {'value': '173.91', 'spread': '9.896', 'groupId': 'BG001'}, {'value': '174.30', 'spread': '9.605', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-09', 'size': 812825, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-07T08:40', 'hasProtocol': True}, {'date': '2019-03-06', 'size': 23708187, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-07T08:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2014-12-09', 'resultsFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-30', 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting Toxicities (DLTs)', 'timeFrame': '28 days after first administration of combination treatment (BBI608+TMZ)', 'description': 'Number of patients who experienced a dose limiting toxicity following a dosing of BBI608'}, {'measure': 'Progression Free Survival (PFS)-6', 'timeFrame': 'From the time of exposure to study drug to first objective documentation of disease progression or death due to any cause, assessed up to 6 months', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) therapy defined as the percentage of patients who have survived without objective disease progression for at least 6 months after treatment per neuro-oncology (RANO) criteria who had evaluable disease at baseline. PFS-6 is defined as the percentage of patients who survived without objective disease progression per RANO criteria for at least 6 months after treatment.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)-12', 'timeFrame': 'From the time of exposure to study drug to first objective documentation of disease progression or death due to any cause, up to 12 months', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) therapy defined as the percentage of patients who have survived without objective disease progression for at least 12 months after treatment per neuro-oncology (RANO) criteria who had evaluable disease at baseline. PFS-12 is defined as the percentage of patients who survived without objective disease progression per RANO criteria for at least 12 months after treatment.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the time of exposure to study drug to death from any cause. If patient discontinued study drug, they were assessed the first 3 months after discontinuation, then every 3 months up to 1 year, then every 6 months thereafter until death.', 'description': 'To assess the effect of BBI608 + temozolomide (TMZ) on the overall survival of patients with recurrent or progressive glioblastoma multiforme (GBM) who had not received prior treatment with bevacizumab or other anti-vascular endothelial growth factor agents who either were eligible or not eligible for surgical resection.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '4 weeks', 'description': 'To assess the percentage of patients that had evaluable disease at baseline with a documented complete response, partial response, and stable disease (CR + PR + SD) based on the Response Assessment in Neuro-Oncology (RANO) criteria out of all patients who received at least one dose of any study drug and had evaluable disease at baseline.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': '4 weeks', 'description': 'The proportion of patients with a documented complete response and partial response (CR + PR) based on RANO criteria.'}, {'measure': 'Pharmacokinetic Profile of BBI608 and Temozolomide When Administered in Combination With Temozolomide as Assessed by the Area Under the Curve', 'timeFrame': 'On Day 1 and Day 5 after the first dosing, prior to dosing and 1, 2, 3, 5, 5h40m (day 1 only), 6, 7, 8 and 24 hours after first dose of BBI608', 'description': 'The area under the curve of BBI608, from time 0 to the last quantifiable concentration, calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method)'}, {'measure': 'Pharmacodynamic Activity of BBI608 When Administered in Combination With Temozolomide as Assessed by Tumor Biopsy and Cancer Stem Cell Assays as Well as the Concentration of Study Drug in Tumors', 'timeFrame': 'At the time of surgical resection', 'description': 'Tumor samples to provide information of the biomarkers by histopathology and Cancer Stem Cell assays as well as the concentration of study drug in tumors.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GBM', 'Malignant Glioma'], 'conditions': ['Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This is an open label, multi-center, phase 1 safety run-in and phase 2 study of BBI608 in combination with temozolomide in patients with recurrent or progressive glioblastoma who have not received prior bevacizumab therapy.', 'detailedDescription': 'In arm A, patients who are candidates for surgical resection will receive BBI608 as monotherapy prior to resection, followed by post-operative BBI608 administered in combination with temozolomide. In arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, in combination with temozolomide.\n\nIn the phase 1/dose-limiting toxicity (DLT) cohort portion of this study, pharmacokinetics will be evaluated for both arms A and B. Pharmacodynamics will be evaluated in all patients who undergo surgical resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Eligibility Criteria\n\n1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements.\n2. A histologically confirmed supratentorial glioblastoma (GBM) at first recurrence/progression (except for transformation from previous low grade glioma) following standard front-line therapy, for which treatment with temozolomide (TMZ) would be acceptable as determined by the Investigator\n3. Previously received standard front-line GBM treatment including maximal surgical resection followed by external beam radiation therapy.\n4. Patients may or may not be candidates for repeat surgical resection of the recurrent/progressed GBM.\n5. Patients must have unequivocal evidence of tumor recurrence/progression by MRI at a minimum of 12 weeks following completion of chemoradiation or radiation therapy.\n6. Patients must have measurable or non-measurable disease by response assessment in neuro-oncology Response Assessment in Neuro-oncology (RANO) criteria'}, 'identificationModule': {'nctId': 'NCT02315534', 'briefTitle': 'A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A Phase Ib/II Clinical Study of BBI608 in Combination With Temozolomide for Adult Patients With Recurrent or Progressed Glioblastoma', 'orgStudyIdInfo': {'id': 'BBI608-251'}, 'secondaryIdInfos': [{'id': 'BBI608-201GBM', 'type': 'OTHER', 'domain': 'Boston Biomedical, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Patients for whom surgery is recommended as part of treatment for recurrent Glioblastoma.', 'interventionNames': ['Drug: BBI608', 'Drug: Temozolomide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Patients for whom surgery is not recommended as part of the treatment for recurrent Glioblastoma.', 'interventionNames': ['Drug: BBI608', 'Drug: Temozolomide']}], 'interventions': [{'name': 'BBI608', 'type': 'DRUG', 'otherNames': ['Napabucasin', 'BB608', 'BBI-608'], 'description': 'In arm A, BBI608 will be administered at the recommended Phase 2 dose (RP2D) twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide.\n\nIn arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the RP2D in combination with temozolomide.', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar'], 'description': 'Temozolomide (TMZ) will be administered orally, once daily, at a dose of 150 mg/m\\^2 daily on days 1 through 5 of each 28-day study cycle. The dose of temozolomide can be increased to 200 mg/m\\^2 as per standard TMZ dosing guidelines for patients who complete at least one cycle at 150 mg/m\\^2.', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}