Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00830869
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C548400', 'term': 'ixazomib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Part 1: Cycle 10 Day 41, Part 2: Cycle 12 Day 41)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 2, 'seriousNumAffected': 10}, {'id': 'EG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 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system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21', 'description': 'Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\\<500 cells/cubic meter\\[cells/mm\\^3\\])for\\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \\<25,000 cells/mm3)for\\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\\<10,000 cells/mm3; GR 3 peripheral neuropathy;\\>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; \\>=GR 3 diarrhoea in absence of optimal supportive therapy;GR 3 QTc prolongation noted on average of 3 electrocardiograms (ECGs);\\>=GR 3 nonhematological toxicity except GR 3 arthralgia/myalgia or GR 3 fatigue for\\<1 week; Delay in initiation of subsequent therapy cycle by\\>7 days due to treatment-related toxicity Other\\>=GR 2 nonhematological toxicity that opinion of investigator, requires discontinuation of therapy with Ixazomib.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT population included all participants who received all Cycle 1 doses of ixazomib and who had completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'OG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'OG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'OG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'OG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'OG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'OG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'OG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'OG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'classes': [{'title': 'Liver function analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Renal function analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Tissue enzyme analyses notelsewhereclassified(NEC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}, {'title': 'Red blood cell analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Platelet analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Mineral and electrolyte analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}, {'title': 'Metabolism tests NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Urinalysis NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'White blood cell analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Thrombocytopenias', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}]}]}, {'title': 'Anaemias NEC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}]}, {'title': 'Leukopenias NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}]}, {'title': 'Neutropenias', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}, {'title': 'Leukocytoses NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Marrow depression and hypoplastic anaemias', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Thrombocytoses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Sodium imbalance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}]}, {'title': 'Hyperglycaemic conditions NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Potassium imbalance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}, {'title': 'Calcium metabolism disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Magnesium metabolism disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Disorders of purine metabolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Metabolic acidoses (excluding diabetic acidoses)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Phosphorus metabolism disorders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Protein metabolism disorders NEC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Coagulation and bleeding analyses', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '22', 'groupId': 'OG008'}, {'value': '20', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'OG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'OG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'OG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'OG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)', 'description': 'Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '91.6', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '191.87', 'spread': '40.211', 'groupId': 'OG003'}, {'value': '391.46', 'spread': '92.446', 'groupId': 'OG004'}, {'value': '522.74', 'spread': '120.122', 'groupId': 'OG005'}, {'value': '620.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '301.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '579.91', 'spread': '246.505', 'groupId': 'OG003'}, {'value': '1161.92', 'spread': '424.774', 'groupId': 'OG004'}, {'value': '1542.64', 'spread': '454.015', 'groupId': 'OG005'}, {'value': '3800.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population where data at specified time points was available,defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions, did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG000'}, {'value': '82.5', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '192.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '346.70', 'spread': '170.208', 'groupId': 'OG003'}, {'value': '366.16', 'spread': '146.167', 'groupId': 'OG004'}, {'value': '579.54', 'spread': '210.672', 'groupId': 'OG005'}, {'value': '901.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG000'}, {'value': '69.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '83.8', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '272.57', 'spread': '64.044', 'groupId': 'OG003'}, {'value': '390.08', 'spread': '209.538', 'groupId': 'OG004'}, {'value': '648.97', 'spread': '597.508', 'groupId': 'OG005'}, {'value': '869.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'C0 is the plasma drug concentration at time zero following bolus intravenous injection.', 'unitOfMeasure': 'nanogram per mililiter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population where data at specified time points was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Part 1: Rac: Accumulation Ratio for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.210', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG000'}, {'value': '5.160', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '3.290', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '2.996', 'spread': '1.5948', 'groupId': 'OG003'}, {'value': '2.831', 'spread': '0.7228', 'groupId': 'OG004'}, {'value': '3.086', 'spread': '0.4998', 'groupId': 'OG005'}, {'value': '6.130', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '171.90', 'spread': '38.070', 'groupId': 'OG003'}, {'value': '144.69', 'spread': '27.647', 'groupId': 'OG004'}, {'value': '104.84', 'spread': '39.646', 'groupId': 'OG005'}, {'value': '90.80', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'T1/2 is the time required for half of the drug to be eliminated from the plasma.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis population defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive excluded concomitant medications in Cycle 1,had sufficient concentration-time data to permit estimation of PK parameters.'}, {'type': 'SECONDARY', 'title': 'Part 1: E Max: Maximum Observed Effect for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '7.70', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG000'}, {'value': '17.90', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '28.20', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '35.22', 'spread': '8.592', 'groupId': 'OG003'}, {'value': '46.73', 'spread': '9.424', 'groupId': 'OG004'}, {'value': '62.20', 'spread': '9.862', 'groupId': 'OG005'}, {'value': '67.40', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}, {'title': 'Cycle 1 Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG000'}, {'value': '10.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG001'}, {'value': '46.10', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG002'}, {'value': '39.33', 'spread': '8.868', 'groupId': 'OG003'}, {'value': '54.30', 'spread': '4.058', 'groupId': 'OG004'}, {'value': '61.90', 'spread': '9.042', 'groupId': 'OG005'}, {'value': '70.40', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'E max is the maximum inhibition of 20S proteasome activity in whole blood.', 'unitOfMeasure': 'percentage of inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis population where baseline/post-baseline assessments was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive any excluded concomitant medications in Cycle 1,had sufficient effect-time data to permit estimation of PD parameters.'}, {'type': 'SECONDARY', 'title': 'Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '0.100', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.10'}, {'value': '0.250', 'groupId': 'OG002', 'lowerLimit': '0.25', 'upperLimit': '0.25'}, {'value': '0.100', 'groupId': 'OG003', 'lowerLimit': '0.08', 'upperLimit': '0.10'}, {'value': '0.250', 'groupId': 'OG004', 'lowerLimit': '0.10', 'upperLimit': '0.25'}, {'value': '0.080', 'groupId': 'OG005', 'lowerLimit': '0.07', 'upperLimit': '0.10'}, {'value': '0.080', 'groupId': 'OG006', 'lowerLimit': '0.08', 'upperLimit': '0.08'}]}]}, {'title': 'Cycle 1 Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '24.000', 'groupId': 'OG000', 'lowerLimit': '24.00', 'upperLimit': '24.00'}, {'value': '0.080', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.08'}, {'value': '0.100', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '0.10'}, {'value': '0.110', 'groupId': 'OG003', 'lowerLimit': '0.10', 'upperLimit': '0.12'}, {'value': '0.080', 'groupId': 'OG004', 'lowerLimit': '0.08', 'upperLimit': '0.10'}, {'value': '0.120', 'groupId': 'OG005', 'lowerLimit': '0.08', 'upperLimit': '0.18'}, {'value': '0.100', 'groupId': 'OG006', 'lowerLimit': '0.10', 'upperLimit': '0.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'TEmax is the time to reach the Emax, equal to time (hours) to Emax.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PD analysis population where baseline/post-baseline assessments was available, defined as participants in dose escalation phase who received protocol-specified dosing in Cycle 1 without dose reductions/interruptions,did not receive any excluded concomitant medications in Cycle 1,had sufficient effect-time data to permit estimation of PD parameters.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Best Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '14', 'groupId': 'OG008'}, {'value': '16', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '17', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'OG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'OG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'OG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'OG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}]}, {'title': 'Progressive disease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)', 'description': 'Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above normal limits. Progressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The response-evaluable population included all participants who received at least 1 cycle of ixazomib treatment, had measurable disease at baseline, and had at least 1 postbaseline response assessment.'}, {'type': 'SECONDARY', 'title': 'Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '525', 'spread': '342', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose', 'description': 'The average data of Days 1 and 4 of Cycle 1 was reported.', 'unitOfMeasure': 'nanogram per gram (ng/g)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The tumor PK analysis set where Day 1 and 4 assessment were available. The tumor PK and PD analysis population includes all participants who provided a baseline tumor biopsy sample and 1 post-baseline tumor biopsy sample on Day 1 or Day 4.'}, {'type': 'SECONDARY', 'title': '20S Proteasome Activity of Ixazomib in the Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'OG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'OG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'OG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'OG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'OG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}], 'timeFrame': 'Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed due to lack of tumor activity data.'}, {'type': 'SECONDARY', 'title': 'Expression of Biomarker (ATF-3) in Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 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{'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '14'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '12'}, {'groupId': 'FG010', 'numSubjects': '8'}, {'groupId': 'FG011', 'numSubjects': '15'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 7 investigative sites in the United States and Canada from 02 March 2009 to 20 April 2012.', 'preAssignmentDetails': 'Participants with diagnosis of nonhematologic malignancies were enrolled in 1 of the 2 parts, Part 1: Dose escalation to determine maximum tolerated dose (MTD), and Part 2: Expansion at MTD in 5 expansion cohorts.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '22', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '116', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Ixazomib 0.125 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.125 milligram per square meter (mg/m\\^2), injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG001', 'title': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG002', 'title': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG003', 'title': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG004', 'title': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG005', 'title': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG006', 'title': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.'}, {'id': 'BG007', 'title': 'Part 2:Ixazomib 1.76 mg/m^2-Non-small Cell Lung Cancer(NSCLC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.'}, {'id': 'BG008', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Head and Neck Cancer (H&N)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.'}, {'id': 'BG009', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Soft Tissue Sarcoma (STC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.'}, {'id': 'BG010', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-Prostate Cancer (PC)', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.'}, {'id': 'BG011', 'title': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG000'}, {'value': '55.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG001'}, {'value': '69.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG002'}, {'value': '55.1', 'spread': '10.71', 'groupId': 'BG003'}, {'value': '59.8', 'spread': '14.22', 'groupId': 'BG004'}, {'value': '62.3', 'spread': '10.98', 'groupId': 'BG005'}, {'value': '64.7', 'spread': '10.79', 'groupId': 'BG006'}, {'value': '58.6', 'spread': '11.50', 'groupId': 'BG007'}, {'value': '55.1', 'spread': '9.99', 'groupId': 'BG008'}, {'value': '55.0', 'spread': '9.43', 'groupId': 'BG009'}, {'value': '63.1', 'spread': '5.49', 'groupId': 'BG010'}, {'value': '57.6', 'spread': '11.24', 'groupId': 'BG011'}, {'value': '57.8', 'spread': '10.32', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '50', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '66', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}, {'value': '97', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '17', 'groupId': 'BG012'}]}]}], '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': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}, {'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'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'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': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '17', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '12', 'groupId': 'BG011'}, {'value': '95', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '106', 'groupId': 'BG012'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '10', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG000'}, {'value': '173.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG001'}, {'value': '156.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG002'}, {'value': '168.9', 'spread': '8.19', 'groupId': 'BG003'}, {'value': '163.3', 'spread': '9.54', 'groupId': 'BG004'}, {'value': '167.8', 'spread': '11.44', 'groupId': 'BG005'}, {'value': '178.3', 'spread': '5.69', 'groupId': 'BG006'}, {'value': '170.0', 'spread': '7.61', 'groupId': 'BG007'}, {'value': '173.8', 'spread': '9.11', 'groupId': 'BG008'}, {'value': '164.2', 'spread': '11.54', 'groupId': 'BG009'}, {'value': '178.3', 'spread': '6.72', 'groupId': 'BG010'}, {'value': '171.4', 'spread': '9.23', 'groupId': 'BG011'}, {'value': '170.4', 'spread': '9.91', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.70', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG000'}, {'value': '65.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG001'}, {'value': '64.00', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG002'}, {'value': '73.37', 'spread': '20.517', 'groupId': 'BG003'}, {'value': '66.33', 'spread': '16.589', 'groupId': 'BG004'}, {'value': '70.90', 'spread': '21.377', 'groupId': 'BG005'}, {'value': '85.47', 'spread': '14.086', 'groupId': 'BG006'}, {'value': '70.87', 'spread': '11.160', 'groupId': 'BG007'}, {'value': '69.00', 'spread': '12.448', 'groupId': 'BG008'}, {'value': '74.06', 'spread': '19.650', 'groupId': 'BG009'}, {'value': '94.20', 'spread': '14.321', 'groupId': 'BG010'}, {'value': '91.44', 'spread': '30.468', 'groupId': 'BG011'}, {'value': '77.17', 'spread': '20.794', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body surface area', 'classes': [{'categories': [{'measurements': [{'value': '1.90', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG000'}, {'value': '1.80', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG001'}, {'value': '1.70', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated since only 1 participant was available for analysis.', 'groupId': 'BG002'}, {'value': '1.83', 'spread': '0.298', 'groupId': 'BG003'}, {'value': '1.73', 'spread': '0.250', 'groupId': 'BG004'}, {'value': '1.82', 'spread': '0.331', 'groupId': 'BG005'}, {'value': '2.03', 'spread': '0.153', 'groupId': 'BG006'}, {'value': '1.82', 'spread': '0.151', 'groupId': 'BG007'}, {'value': '1.82', 'spread': '0.197', 'groupId': 'BG008'}, {'value': '1.84', 'spread': '0.276', 'groupId': 'BG009'}, {'value': '2.15', 'spread': '0.181', 'groupId': 'BG010'}, {'value': '2.08', 'spread': '0.383', 'groupId': 'BG011'}, {'value': '1.90', 'spread': '0.282', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'square meter (m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety population included all participants who received at least 1 dose of ixazomib.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2012-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2009-01-26', 'resultsFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-30', 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Dose Limiting Toxicity (DLT)', 'timeFrame': 'Part 1: Cycle 1 Day 1 up to Cycle 1 Day 21', 'description': 'Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLT is any of following related to ixazomib:Grade (GR) 4 neutropenia (absolute neutrophil count\\<500 cells/cubic meter\\[cells/mm\\^3\\])for\\>7 days; GR 3 neutropenia with coincident fever and/or infection; GR 4 thrombocytopenia (platelets \\<25,000 cells/mm3)for\\>7 days; GR 3 thrombocytopenia with clinically significant bleeding; Platelet count\\<10,000 cells/mm3; GR 3 peripheral neuropathy;\\>=GR 3 nausea/emesis in absence of optimal antiemetic therapy; \\>=GR 3 diarrhoea in absence of optimal supportive therapy;GR 3 QTc prolongation noted on average of 3 electrocardiograms (ECGs);\\>=GR 3 nonhematological toxicity except GR 3 arthralgia/myalgia or GR 3 fatigue for\\<1 week; Delay in initiation of subsequent therapy cycle by\\>7 days due to treatment-related toxicity Other\\>=GR 2 nonhematological toxicity that opinion of investigator, requires discontinuation of therapy with Ixazomib.'}, {'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAEs)', 'timeFrame': 'Part 1: Cycle 1 Day 1 up to Cycle 10 Day 41; Part 2: Cycle 1 Day 1 up to Cycle 12 Day 41'}, {'measure': 'Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Day 1 up to 30 days after last dose of study drug (Cycle 12 Day 41)', 'description': 'Vital sign measurements included diastolic and systolic blood pressure, heart rate, weight and oral temperature.'}], 'secondaryOutcomes': [{'measure': 'Part 1: AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for Ixazomib', 'timeFrame': 'Part 1: Cycle 1 Days 1 and 11: pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'AUC (0-72) is a measure of the area under the plasma concentration-time curve from time 0 to 72 hours post-dose for ixazomib.'}, {'measure': 'Part 1: C0: Initial Plasma Concentration After Bolus Intravenous Administration', 'timeFrame': 'Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'C0 is the plasma drug concentration at time zero following bolus intravenous injection.'}, {'measure': 'Part 1: Rac: Accumulation Ratio for Ixazomib', 'timeFrame': 'Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose', 'description': 'Rac was estimated as the ratio of AUC (0-72) on Day 11 and AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time 0 to 72 hours post-dose.'}, {'measure': 'Part 1: Terminal Phase Elimination Half-life (T1/2) for Ixazomib', 'timeFrame': 'Part 1: Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'T1/2 is the time required for half of the drug to be eliminated from the plasma.'}, {'measure': 'Part 1: E Max: Maximum Observed Effect for Ixazomib', 'timeFrame': 'Part 1: Cycle 1 Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'E max is the maximum inhibition of 20S proteasome activity in whole blood.'}, {'measure': 'Part 1: TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib', 'timeFrame': 'Part 1: Cycle 1 Days 1 and 11 pre-dose and at multiple time points (up to 72 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 264 hours) post-dose', 'description': 'TEmax is the time to reach the Emax, equal to time (hours) to Emax.'}, {'measure': 'Number of Participants With Best Overall Response', 'timeFrame': 'Day 18 up to Day 21 of each cycle (Part 1: up to Cycle 10; Part 2: up to Cycle 12)', 'description': 'Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above normal limits. Progressive disease: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.'}, {'measure': 'Part 2: Ixazomib Concentration in Postdose Clinical Tumor Samples in Ixazomib 1.76 mg/m^2-TPEC', 'timeFrame': 'Cycle 1 Days 1 and 4: Predose and (from 4-20 hours) post-dose', 'description': 'The average data of Days 1 and 4 of Cycle 1 was reported.'}, {'measure': '20S Proteasome Activity of Ixazomib in the Tumor Tissue', 'timeFrame': 'Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose'}, {'measure': 'Expression of Biomarker (ATF-3) in Tumor Tissue', 'timeFrame': 'Cycle 1 Days 1 and 4 pre-dose and at multiple time points (up to 2 hours of tumor biopsy) post-dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Advanced Non-hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB administered intravenously in participants with nonhematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach participant must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Male or female participants 18 years or older.\n2. Eastern Cooperative Oncology Group performance status 0-2.\n3. A diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective. In the expanded cohort, enrollment will be limited to participants with a diagnosis of NSCLC, H\\&N cancer (squamous cell cancer), STS, or PC.\n4. Suitable venous access for pharmacokinetic (PK) and pharmacodynamic evaluations.\n5. Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.\n\n Male participants who agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.\n6. Voluntary written consent must be obtained.\n7. Adequate clinical laboratory values during the screening period.\n8. In the escalation portion of the study, radiographically or clinically evaluable tumor was required, but measurable disease as defined by response evaluation criteria in solid tumors (RECIST) criteria was not required. In the MTD disease expansion cohorts and the TPEC, clinically measurable disease as defined by RECIST criteria was required for evaluation of NSCLC, H\\&N cancer, and STS. Prostate specific antigen (PSA) alone was acceptable for evaluation of PC.\n9. For participants in the TPEC, tumor tissue that, in the opinion of the investigator, could have been safely biopsied using a core needle.\n\nExclusion Criteria:\n\nParticipants meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Peripheral neuropathy greater than or equal to (\\>=) Grade 2.\n2. Female participants who are lactating or have a positive serum pregnancy test during the screening period.\n3. Major surgery within 14 days before the first dose of treatment.\n4. Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment.\n5. Life-threatening illness unrelated to cancer.\n6. Diarrhea greater than (\\>) Grade 1 based on the National Cancer Institute Common Terminology .Criteria for Adverse Events (NCI CTCAE) categorization.\n7. Systemic antineoplastic therapy / or radiotherapy within 21 days before the first dose of study treatment.\n8. Systemic treatment with prohibited medications.\n9. Participant has symptomatic brain metastasis.\n10. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or myocardial infarction within the past 6 months.\n11. QTc \\>470 milliseconds (msec) on a 12-lead electrocardiogram (ECG) obtained during the screening period.\n12. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C positive.\n13. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n14. Treatment with any investigational products within 28 days before the first dose of study treatment.\n15. For participants in the TPEC and participants in the MTD disease expansion cohorts who gave informed consent to undergo tumor biopsy, ongoing anticoagulant therapy (example, aspirin, clopidogrel \\[Plavix ®\\], warfarin, or heparin) that cannot be held to permit tumor biopsy .\n16. Known allergy to boron or excipients."}, 'identificationModule': {'nctId': 'NCT00830869', 'briefTitle': 'A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-Label, Dose Escalation, Phase 1 Study of IXAZOMIB (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies', 'orgStudyIdInfo': {'id': 'C16001'}, 'secondaryIdInfos': [{'id': 'U1111-1206-2180', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 0.125 milligram per square meter (mg/m^2)', 'description': 'Ixazomib (MLN9708) 0.125 mg/m\\^2, injection, intravenously (IV), once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 0.25 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.25 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 0.5 mg/m^2', 'description': 'Ixazomib (MLN9708) 0.5 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 1 mg/m^2', 'description': 'Ixazomib (MLN9708) 1 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 1.33 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.33 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 1.76 mg/m^2', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Ixazomib 2.34 mg/m^2', 'description': 'Ixazomib (MLN9708) 2.34 mg/m\\^2, injection, IV, once on Day 1, 4, 8 and 11 followed by 10 days of rest in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity during Part 1 of the study. Once the MTD will be established, participants with NSCLC, Head and Neck Cancer (H\\&N), Soft Tissue Sarcoma (STC) or Prostate Cancer (PC) will be included in MTD disease expanded cohort. An additional tumor pharmacodynamics expansion cohort (TPEC) will enroll participants with any type of solid tumor that can be biopsied for tissue analysis before and after treatment with ixazomib.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2:Ixazomib 1.76 mg/m^2-NSCLC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with NSCLC during Part 2 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Ixazomib 1.76 mg/m^2-H&N', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with H\\&N during Part 2 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Ixazomib 1.76 mg/m^2-STC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with STC during Part 2 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Ixazomib 1.76 mg/m^2-PC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with PC during Part 2 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'description': 'Ixazomib (MLN9708) 1.76 mg/m\\^2, injection, IV, once on Day 1, 4, 8, and 11 followed by 10 days of rest period in 21-day treatment cycles for a maximum of 12 cycles, or until progressive disease or unacceptable toxicity in participants with various types of solid tumors suitable for biopsy in tumor pharmacodynamic expansion cohort (TPEC) during Part 2 of the study.', 'interventionNames': ['Drug: IXAZOMIB']}], 'interventions': [{'name': 'IXAZOMIB', 'type': 'DRUG', 'description': 'All participants will receive IXAZOMIB IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days.\n\nThe first stage of the study will be initiated at a starting dose of 0.125 mg/m\\^2. Subsequent doses will increase until a maximum tolerated dose (MTD) is established.', 'armGroupLabels': ['Part 1: Ixazomib 0.125 milligram per square meter (mg/m^2)', 'Part 1: Ixazomib 0.25 mg/m^2', 'Part 1: Ixazomib 0.5 mg/m^2', 'Part 1: Ixazomib 1 mg/m^2', 'Part 1: Ixazomib 1.33 mg/m^2', 'Part 1: Ixazomib 1.76 mg/m^2', 'Part 1: Ixazomib 2.34 mg/m^2', 'Part 2: Ixazomib 1.76 mg/m^2-H&N', 'Part 2: Ixazomib 1.76 mg/m^2-PC', 'Part 2: Ixazomib 1.76 mg/m^2-STC', 'Part 2: Ixazomib 1.76 mg/m^2-TPEC', 'Part 2:Ixazomib 1.76 mg/m^2-NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington- Seattle Cancer Care', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}