Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02895360
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599741', 'term': 'lisavanbulin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Thomas.Kaindl@basilea.com', 'phone': '+41615671505', 'title': 'Thomas Kaindl, MD, Global Medical Director, Oncology', 'organization': 'Basilea Pharmaceutica International Ltd.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug through 28 days after the administration of the last dose', 'description': 'TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 - 30 mg/m² Cohort', 'description': 'BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase 1 - 45 mg/m² Cohort', 'description': 'BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1 - 70 mg/m² Cohort', 'description': 'BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 3, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Phase 1 - 90 mg/m² Cohort', 'description': 'BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Phase 2a - Ovarian Cancer Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 3, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Phase 2a - Recurrent Glioblastoma Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Troponin T increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder neoplasm surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of BAL101553', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MTD-determining Population in Phase 1', 'description': 'All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 day cycle', 'description': 'First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels', 'unitOfMeasure': 'mg/m²', 'reportingStatus': 'POSTED', 'populationDescription': 'MTD-determining population in Phase 1: All patients who meet the following minimum criteria during the first 28-day treatment cycle (Cycle 1)\n\n* received at least one partial or complete dose of BAL101553 and has experienced a DLT;\n* received all three doses of BAL101553 without experiencing a DLT (including the ability to initiate treatment Cycle 2), have been observed for ≥ 28 days following the first dose, and have been evaluated for safety.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 - 30 mg/m² Cohort', 'description': 'BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².'}, {'id': 'OG001', 'title': 'Phase 1 - 45 mg/m² Cohort', 'description': 'BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².'}, {'id': 'OG002', 'title': 'Phase 1 - 70 mg/m² Cohort', 'description': 'BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².'}, {'id': 'OG003', 'title': 'Phase 1 - 90 mg/m² Cohort', 'description': 'BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².'}, {'id': 'OG004', 'title': 'Phase 2a - Ovarian Cancer Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'OG005', 'title': 'Phase 2a - Recurrent Glioblastoma Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}], 'classes': [{'title': 'Patients with ≥1 related AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Patients with CTCAE Grade 3/4 or severe related AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Patients with ≥1 related serious AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose', 'description': 'TEAEs are defined as all events occurring after BAL101553 treatment begins, up to 28 days after last study drug administration according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who receive at least one full or partial dose of BAL101553 and had at least one post-baseline safety assessment is included in the safety analysis population.'}, {'type': 'SECONDARY', 'title': 'AUC of BAL101553 and BAL27862', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG001', 'title': '30 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG002', 'title': '45 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG003', 'title': '45 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG004', 'title': '70 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG005', 'title': '70 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG006', 'title': '90 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG007', 'title': '90 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 2 Day 1'}], 'classes': [{'title': 'BAL101553', 'categories': [{'measurements': [{'value': '1430', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '1310', 'spread': '47.6', 'groupId': 'OG001'}, {'value': '2260', 'spread': '43.9', 'groupId': 'OG002'}, {'value': '1890', 'spread': '13.3', 'groupId': 'OG003'}, {'value': '3560', 'spread': '45.9', 'groupId': 'OG004'}, {'value': '3550', 'spread': '43.1', 'groupId': 'OG005'}, {'value': '4810', 'spread': '74.0', 'groupId': 'OG006'}, {'value': '4150', 'spread': '67.5', 'groupId': 'OG007'}]}]}, {'title': 'BAL27862', 'categories': [{'measurements': [{'value': '1730', 'spread': '37.8', 'groupId': 'OG000'}, {'value': '2250', 'spread': '58.2', 'groupId': 'OG001'}, {'value': '3440', 'spread': '45.1', 'groupId': 'OG002'}, {'value': '3920', 'spread': '57.7', 'groupId': 'OG003'}, {'value': '7720', 'spread': '44.6', 'groupId': 'OG004'}, {'value': '6640', 'spread': '49.3', 'groupId': 'OG005'}, {'value': '10400', 'spread': '37.2', 'groupId': 'OG006'}, {'value': '10700', 'spread': '39.3', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 168 hours post-dose at Day 1 of Cycle 1 and Cycle 2 in each cohort in Phase 1, 28-day cycles', 'description': 'Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC0-last (of BAL101553 and BAL27862 has been assessed after a 48-hour IV infusion.\n\nLisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.'}, {'type': 'SECONDARY', 'title': 'Cmax of BAL101553 and BAL27862', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG001', 'title': '30 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG002', 'title': '45 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG003', 'title': '45 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG004', 'title': '70 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG005', 'title': '70 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG006', 'title': '90 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG007', 'title': '90 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 2 Day 1'}], 'classes': [{'title': 'BAL101553', 'categories': [{'measurements': [{'value': '43.0', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '69.3', 'spread': '19.3', 'groupId': 'OG002'}, {'value': '60.9', 'spread': '4.3', 'groupId': 'OG003'}, {'value': '119', 'spread': '34.5', 'groupId': 'OG004'}, {'value': '111', 'spread': '34.9', 'groupId': 'OG005'}, {'value': '174', 'spread': '63.6', 'groupId': 'OG006'}, {'value': '198', 'spread': '76.8', 'groupId': 'OG007'}]}]}, {'title': 'BAL27862', 'categories': [{'measurements': [{'value': '45.7', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '45.8', 'groupId': 'OG001'}, {'value': '76.8', 'spread': '18.6', 'groupId': 'OG002'}, {'value': '76.2', 'spread': '43.1', 'groupId': 'OG003'}, {'value': '144', 'spread': '25.7', 'groupId': 'OG004'}, {'value': '120', 'spread': '41.2', 'groupId': 'OG005'}, {'value': '223', 'spread': '44.7', 'groupId': 'OG006'}, {'value': '199', 'spread': '40.4', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.', 'description': 'Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862.\n\nLisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.'}, {'type': 'SECONDARY', 'title': 'Tmax of BAL101553 and BAL27862', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG001', 'title': '30 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 30 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG002', 'title': '45 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG003', 'title': '45 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 45 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG004', 'title': '70 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG005', 'title': '70 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 70 mg/m² Cohort Cycle 2 Day 1'}, {'id': 'OG006', 'title': '90 mg/m² Cycle 1 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 1 Day 1'}, {'id': 'OG007', 'title': '90 mg/m² Cycle 2 Day 1', 'description': 'BAL101553 90 mg/m² Cohort Cycle 2 Day 1'}], 'classes': [{'title': 'BAL101553', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '48.0'}, {'value': '30.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '48.0'}, {'value': '29.0', 'groupId': 'OG002', 'lowerLimit': '4.03', 'upperLimit': '30.0'}, {'value': '27.1', 'groupId': 'OG003', 'lowerLimit': '24.2', 'upperLimit': '30.0'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '24.1'}, {'value': '1.56', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '4.05'}, {'value': '2.53', 'groupId': 'OG006', 'lowerLimit': '1.03', 'upperLimit': '46.5'}, {'value': '1.17', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '3.95'}]}]}, {'title': 'BAL27862', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '48.0'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '52.9'}, {'value': '48.0', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': '48.1'}, {'value': '47.5', 'groupId': 'OG003', 'lowerLimit': '47.2', 'upperLimit': '47.9'}, {'value': '47.6', 'groupId': 'OG004', 'lowerLimit': '29.1', 'upperLimit': '52.1'}, {'value': '46.6', 'groupId': 'OG005', 'lowerLimit': '7.5', 'upperLimit': '54.7'}, {'value': '46.2', 'groupId': 'OG006', 'lowerLimit': '23.8', 'upperLimit': '47.5'}, {'value': '47.4', 'groupId': 'OG007', 'lowerLimit': '46.7', 'upperLimit': '47.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.', 'description': 'Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.'}, {'type': 'SECONDARY', 'title': 'Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '30 mg/m²', 'description': 'Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations'}, {'id': 'OG001', 'title': '45 mg/m²', 'description': 'Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations'}, {'id': 'OG002', 'title': '70 mg/m²', 'description': 'Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations'}, {'id': 'OG003', 'title': '90 mg/m²', 'description': 'Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.796', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '0.893', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Relative oral bioavailability, calculated as dose-normalized AUC0-τ following oral administration on Cycle 2 Day 21 divided by dose normalized AUC0-∞ following IV administration on Cycle 1 Day 1 for each cohort.', 'description': 'Ratio of AUCs of avanbulin after oral and IV administration (relative bioavailability) of BAL101553 (lisavanbulin) which is the prodrug of avanbulin (BAL27862)', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations'}, {'type': 'SECONDARY', 'title': 'Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1- in the FAP', 'description': 'All dose cohorts (30 mg/m², 45 mg/m², 70 mg/m² and 90 mg/m²) of BAL101553 in patients with advanced solid tumors\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2'}, {'id': 'OG001', 'title': 'Phase 2a - Patients With Ovarian Cancer in the FAP', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'OG002', 'title': 'Phase 2a - Patients With Ovarian Cancer in the EEP', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'OG003', 'title': 'Phase 2a - Patients With Recurrent Glioblastoma in the FAP', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'OG004', 'title': 'Phase 2a - Patients With Recurrent Glioblastoma in the EEP', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}], 'classes': [{'categories': [{'title': 'Complete response', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Partial response', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Stable disease', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Progressive disease', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 day cycles', 'description': 'The objective response rate (ORR) was calculated using the efficacy evaluable populations (EEPs in Phase 2a) and the full analysis population (FAP in Phase 1 and Phase 2a) based on RECIST v1.1 guidelines (defines criteria for the radiological assessment in tumor response) for patients with solid tumors (excluding GBM (glioblastoma)) and RANO criteria (assessment Incorporating MRI and clinical factors) for patients with GBM.\n\nORR = Rate of complete and partial responses', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAP:\n\nPatients who receive at least one partial or complete dose of BAL101553.\n\nEEP:\n\nPatients with progressive disease who completed at least Cycle 1 dosing and at least one on-study tumor assessment (clinical or radiological by RECIST v1.1 or RANO criteria) Patients with stable disease, partial or complete response, based on a radiological assessment by RECIST v1.1 or RANO criteria at the end of Cycle 2, with at least 4 doses of study drug in the first two cycles.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1 - 30 mg/m² Cohort', 'description': 'BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².'}, {'id': 'FG001', 'title': 'Phase 1 - 45 mg/m² Cohort', 'description': 'BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².'}, {'id': 'FG002', 'title': 'Phase 1 - 70 mg/m² Cohort', 'description': 'BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².'}, {'id': 'FG003', 'title': 'Phase 1 - 90 mg/m² Cohort', 'description': 'BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².'}, {'id': 'FG004', 'title': 'Phase 2a - Ovarian Cancer Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 as 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'FG005', 'title': 'Phase 2a - Recurrent Glioblastoma Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD)\n\nBAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}], 'periods': [{'title': 'Phase 1 - 30 mg/m² Cohort', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1 - 45 mg/m² Cohort', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1 - 70 mg/m² Cohort', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 1 - 90 mg/m² Cohort', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 2a', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '30 mg/m² Cohort', 'description': 'BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².'}, {'id': 'BG001', 'title': '45 mg/m² Cohort', 'description': 'BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².'}, {'id': 'BG002', 'title': '70 mg/m² Cohort', 'description': 'BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².'}, {'id': 'BG003', 'title': '90 mg/m² Cohort', 'description': 'BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².'}, {'id': 'BG004', 'title': 'Phase 2a - Ovarian Cancer Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'BG005', 'title': 'Phase 2a - Recurrent Glioblastoma Cohort', 'description': 'BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '3.30', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '0', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '10.53', 'groupId': 'BG002'}, {'value': '63.0', 'spread': '7.26', 'groupId': 'BG003'}, {'value': '64.7', 'spread': '8.78', 'groupId': 'BG004'}, {'value': '59.3', 'spread': '7.45', 'groupId': 'BG005'}, {'value': '60.7', 'spread': '8.25', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', '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'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', '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'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-08', 'size': 2200551, 'label': 'Study Protocol and Statistical Analysis Plan: Study Protocol', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-04T05:15', 'hasProtocol': True}, {'date': '2018-11-15', 'size': 508529, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-04T05:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2016-09-05', 'resultsFirstSubmitDate': '2021-08-05', 'studyFirstSubmitQcDate': '2016-09-05', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-14', 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) of BAL101553', 'timeFrame': '28 day cycle', 'description': 'First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication', 'timeFrame': 'TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose', 'description': 'TEAEs are defined as all events occurring after BAL101553 treatment begins, up to 28 days after last study drug administration according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03'}, {'measure': 'AUC of BAL101553 and BAL27862', 'timeFrame': '0 to 168 hours post-dose at Day 1 of Cycle 1 and Cycle 2 in each cohort in Phase 1, 28-day cycles', 'description': 'Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC0-last (of BAL101553 and BAL27862 has been assessed after a 48-hour IV infusion.\n\nLisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).'}, {'measure': 'Cmax of BAL101553 and BAL27862', 'timeFrame': 'Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.', 'description': 'Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862.\n\nLisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).'}, {'measure': 'Tmax of BAL101553 and BAL27862', 'timeFrame': 'Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.', 'description': 'Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862'}, {'measure': 'Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1', 'timeFrame': 'Relative oral bioavailability, calculated as dose-normalized AUC0-τ following oral administration on Cycle 2 Day 21 divided by dose normalized AUC0-∞ following IV administration on Cycle 1 Day 1 for each cohort.', 'description': 'Ratio of AUCs of avanbulin after oral and IV administration (relative bioavailability) of BAL101553 (lisavanbulin) which is the prodrug of avanbulin (BAL27862)'}, {'measure': 'Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria', 'timeFrame': '28 day cycles', 'description': 'The objective response rate (ORR) was calculated using the efficacy evaluable populations (EEPs in Phase 2a) and the full analysis population (FAP in Phase 1 and Phase 2a) based on RECIST v1.1 guidelines (defines criteria for the radiological assessment in tumor response) for patients with solid tumors (excluding GBM (glioblastoma)) and RANO criteria (assessment Incorporating MRI and clinical factors) for patients with GBM.\n\nORR = Rate of complete and partial responses'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36792805', 'type': 'DERIVED', 'citation': 'Joerger M, Hundsberger T, Haefliger S, von Moos R, Hottinger AF, Kaindl T, Engelhardt M, Marszewska M, Lane H, Roth P, Stathis A. Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study. Invest New Drugs. 2023 Apr;41(2):267-275. doi: 10.1007/s10637-023-01336-9. Epub 2023 Feb 16.'}, {'pmid': '31471863', 'type': 'DERIVED', 'citation': 'Joerger M, Stathis A, Metaxas Y, Hess D, Mantiero M, Mark M, Volden M, Kaindl T, Engelhardt M, Larger P, Lane H, Hafner P, Levy N, Stuedeli S, Sessa C, von Moos R. A Phase 1 study of BAL101553, a novel tumor checkpoint controller targeting microtubules, administered as 48-h infusion in adult patients with advanced solid tumors. Invest New Drugs. 2020 Aug;38(4):1067-1076. doi: 10.1007/s10637-019-00850-z. Epub 2019 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'Single-agent, open-label, multi-center sequential dose escalation and expansion study of BAL101553, administered as an intravenous (IV) infusion over 48 hours to adults with advanced or recurrent solid tumors or recurrent glioblastoma.', 'detailedDescription': 'This is the first study of prolonged intravenous infusion of BAL101553 (lisavanbulin). BAL101553 will be administered as an intravenous infusion over 48 hours, to adults with advanced or recurrent solid tumors or recurrent glioblastoma who have failed standard therapy, or for whom no effective standard therapy is available.\n\nThe primary goal of the study is to find the highest dose of BAL101553 that can safely be given to humans and to assess what side effects occur. The study will start by treating patients with a low dose. Once it has been shown that this low dose is well tolerated, new patients will be treated at higher dose levels ("dose escalation"). Once the highest, well tolerated dose is identified, up to 20 new patients with platinum-resistant/refractory ovarian cancer and up to 20 new patients with recurrent glioblastoma will be treated at that dose (this part is called "dose expansion") to further assess as secondary goal the tolerability and potential anticancer activity of BAL101553. A further secondary goal of this study is to assess the pharmacokinetics of BAL101553.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Phase 1: Patients with either histologically or cytologically confirmed advanced or recurrent solid tumor, who failed standard therapy or for whom no effective standard therapy is available.\n\n Phase 2a: Patients with platinum-resistant/refractory ovarian, fallopian tube or primary peritoneal cancer (high-grade serous, endometrioid, or carcinosarcoma histotypes) or glioblastoma in first relapse.\n3. Patients with solid tumors must have measurable disease according to Response Evaluation Criteria in Solid Tumors \\[RECIST\\] v1.1.\n\n Patients with recurrent glioblastoma must have measurable disease defined by contrast-enhancing magnetic resonance imaging.\n4. Life expectancy ≥ 12 weeks\n5. Acceptable organ and marrow function at baseline (protocol defined laboratory parameters)\n6. Patients with solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and patients with recurrent glioblastoma must have an ECOG performance status ≤ 2.\n7. Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n1. Patients with solid tumors who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered from side effects of prior therapies.\n\n Patients with recurrent glioblastoma who have: received radiotherapy within 12 weeks, unless there is a new area of enhancement consistent with recurrent tumor outside the radiation field, or there is histological confirmation of unequivocal tumor progression; received administration of prior antitumor chemotherapy within 4 weeks, or within 6 weeks for nitrosoureas; undergone surgical resection within 4 weeks or a stereotactic biopsy/core biopsy within 1 week prior to starting study drug, or have been treated previously with bevacizumab.\n2. Patients who have had prior exposure to BAL101553.\n3. Peripheral neuropathy ≥ CTCAE grade 2.\n4. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements\n5. Systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg at the screening visit.\n6. Blood pressure (BP) combination treatment with more than two antihypertensive medications.\n7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control.\n8. Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02895360', 'briefTitle': 'Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma', 'orgStudyIdInfo': {'id': 'CDI-CS-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1', 'description': 'Fixed 3+3 dose escalation of BAL101553 in patients with advanced solid tumors', 'interventionNames': ['Drug: BAL101553']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a', 'description': 'BAL101553 at MTD in patients with platinum-resistant/refractory ovarian cancer or recurrent glioblastoma', 'interventionNames': ['Drug: BAL101553 at MTD']}], 'interventions': [{'name': 'BAL101553', 'type': 'DRUG', 'description': 'BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2 (study days 15-21)', 'armGroupLabels': ['Phase 1']}, {'name': 'BAL101553 at MTD', 'type': 'DRUG', 'description': 'BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; treatment with maximum tolerated dose (MTD)', 'armGroupLabels': ['Phase 2a']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Oncology Institute of Southern Switzerland; Ospedale Regionale San Giovanni Bellinzona e Valli', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '7000', 'city': 'Chur', 'country': 'Switzerland', 'facility': 'Cantonal Hospital of Grisons, Department of Oncology/ Haematology', 'geoPoint': {'lat': 46.84986, 'lon': 9.53287}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Cantonal Hospital of St. Gallen, Dep. Medical Oncology & Hematology', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitaetsSpital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Thomas Kaindl, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Basilea Pharmaceutica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basilea Pharmaceutica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}