Viewing Study NCT01351350

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Ignite Creation Date: 2025-12-24 @ 5:01 PM
Ignite Modification Date: 2025-12-28 @ 9:13 AM
Study NCT ID: NCT01351350
Status: COMPLETED
Last Update Posted: 2019-08-08
First Post: 2011-02-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572449', 'term': 'sapanisertib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-866-835-2233', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks)', '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. According to the protocol analysis planned, data was collected as per the dosing schedule.', 'eventGroups': [{'id': 'EG000', 'title': 'MLN0128P 30 or 40 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 2, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hyperammonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oesophageal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Disease Progression', 'notes': 'Two treatment-emergent death occurred during treatment with 9 mg MLN0128 QD×3d QW and 7 mg QD×5d QW dose cohort and are not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Escalation Phase: Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation', 'description': 'Participants from the Dose Escalation Phase who received at least 1 dose of study medication. MLN0128 6,7,8,9 or10 mg QD×3d QW, 30 or 40 mg QW, or 7 mg QD×5d QW of a 4-week cycle in combination with paclitaxel (80 mg/m\\^2) on Days 1, 8, and 15 of Cycle 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1: Days 1 to 28', 'description': 'MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.', 'unitOfMeasure': 'mg (QD×3d QW)', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Dose Escalation Phase: Number of Participants With at Least 1 Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1: Days 1 to 28', 'description': 'DLT was defined as any of the following occurring during Cycle 1 (Days 1-28) and attributable to MLN0128P: Grade ≥ 3 nonhematologic toxicity; Grade 3 thrombocytopenia with hemorrhage; Grade 4 neutropenia lasting \\> 7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever 38.5 degrees C and/or infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75 % of doses of MLN0128 within Cycle 1 due to drug-related toxicity; Any clinically significant occurrence which the investigators and sponsor agree would place participants at undue safety risk; Participants who experienced an adverse event (AE) that met the definition for a DLT.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Dose-Escalation evaluable population included participants who received ≥ 75% of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs (considered as DLT).'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 or 40 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).'}, {'id': 'OG001', 'title': 'MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).'}, {'id': 'OG002', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}, {'id': 'OG003', 'title': 'Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).'}, {'id': 'OG004', 'title': 'Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening and thereafter every 2 cycles of treatment until disease progression (Up to 65.8 weeks)', 'description': 'ORR was defined as the percentage of participants with Complete Response (CR) and Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Each cycle was a 28 day cycle. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all participants who received 1 or more doses of MLN0128 and have adequate baseline and post-baseline data collected.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for MLN0128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '245.0', 'groupId': 'OG000', 'lowerLimit': '136.00', 'upperLimit': '456.00'}, {'value': '345.5', 'groupId': 'OG001', 'lowerLimit': '306.00', 'upperLimit': '385.00'}, {'value': '26.7', 'groupId': 'OG002', 'lowerLimit': '19.10', 'upperLimit': '40.30'}, {'value': '31.1', 'groupId': 'OG003', 'lowerLimit': '20.40', 'upperLimit': '52.40'}, {'value': '41.8', 'groupId': 'OG004', 'lowerLimit': '19.80', 'upperLimit': '79.70'}, {'value': '34.2', 'groupId': 'OG005', 'lowerLimit': '23.90', 'upperLimit': '47.10'}, {'value': '100.0', 'groupId': 'OG006', 'lowerLimit': '57.50', 'upperLimit': '162.00'}, {'value': '53.5', 'groupId': 'OG007', 'lowerLimit': '26.70', 'upperLimit': '101.00'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '242.2', 'groupId': 'OG000', 'lowerLimit': '105.00', 'upperLimit': '356.00'}, {'value': '107.0', 'groupId': 'OG001', 'lowerLimit': '107.00', 'upperLimit': '107.00'}, {'value': '33.8', 'groupId': 'OG002', 'lowerLimit': '14.70', 'upperLimit': '58.70'}, {'value': '45.5', 'groupId': 'OG003', 'lowerLimit': '40.40', 'upperLimit': '50.50'}, {'value': '53.1', 'groupId': 'OG004', 'lowerLimit': '46.00', 'upperLimit': '57.20'}, {'value': '23.0', 'groupId': 'OG005', 'lowerLimit': '10.80', 'upperLimit': '36.60'}, {'value': '80.1', 'groupId': 'OG006', 'lowerLimit': '21.00', 'upperLimit': '166.00'}, {'value': '45.3', 'groupId': 'OG007', 'lowerLimit': '11.60', 'upperLimit': '79.50'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Cmin: Minimum Observed Plasma Concentration for MLN0128', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the change in planned analysis, minimum plasma concentration data was not collected.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '5.92'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '3.83'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '1.03', 'upperLimit': '4.08'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '1.02', 'upperLimit': '5.65'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '3.67', 'upperLimit': '6.00'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '0.53', 'upperLimit': '2.17'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.65', 'upperLimit': '5.53'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': '3.90'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '4.00'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '4.02'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '2.00'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.92', 'upperLimit': '4.00'}, {'value': '5.5', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '5.75'}, {'value': '2.7', 'groupId': 'OG007', 'lowerLimit': '0.50', 'upperLimit': '5.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i.e., C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Tmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Elimination Half-life (T1/2) for MLN0128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '6.36', 'upperLimit': '6.91'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '7.03', 'upperLimit': '7.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for 2 participants in the MLN0128P 6 mg QD×3d QW and 2 participants in the MLN0128P 7 mg QD×3d QW arm.'}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '206.5', 'groupId': 'OG000', 'lowerLimit': '183.00', 'upperLimit': '230.00'}, {'value': '286.0', 'groupId': 'OG001', 'lowerLimit': '269.00', 'upperLimit': '303.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for 2 participants in each the MLN0128P 6 mg QD×3d QW and MLN0128P 7 mg QD×3d QW arms.'}, {'type': 'SECONDARY', 'title': 'AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for MLN0128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '753.7', 'groupId': 'OG000', 'lowerLimit': '428.00', 'upperLimit': '1290.00'}, {'value': '1325.0', 'groupId': 'OG001', 'lowerLimit': '1210.00', 'upperLimit': '1440.00'}, {'value': '104.4', 'groupId': 'OG002', 'lowerLimit': '73.70', 'upperLimit': '146.00'}, {'value': '121.7', 'groupId': 'OG003', 'lowerLimit': '82.70', 'upperLimit': '187.00'}, {'value': '139.9', 'groupId': 'OG004', 'lowerLimit': '58.00', 'upperLimit': '282.00'}, {'value': '146.2', 'groupId': 'OG005', 'lowerLimit': '99.20', 'upperLimit': '229.00'}, {'value': '347.0', 'groupId': 'OG006', 'lowerLimit': '203.00', 'upperLimit': '505.00'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '883.6', 'groupId': 'OG000', 'lowerLimit': '464.00', 'upperLimit': '1340.00'}, {'value': '505.0', 'groupId': 'OG001', 'lowerLimit': '505.00', 'upperLimit': '505.00'}, {'value': '106.8', 'groupId': 'OG002', 'lowerLimit': '55.50', 'upperLimit': '165.00'}, {'value': '174.0', 'groupId': 'OG003', 'lowerLimit': '162.00', 'upperLimit': '186.00'}, {'value': '210.3', 'groupId': 'OG004', 'lowerLimit': '143.00', 'upperLimit': '253.00'}, {'value': '72.6', 'groupId': 'OG005', 'lowerLimit': '28.10', 'upperLimit': '144.00'}, {'value': '283.9', 'groupId': 'OG006', 'lowerLimit': '65.60', 'upperLimit': '660.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 30 and 40 mg QW arms.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters. Here, number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2538.0', 'groupId': 'OG000', 'lowerLimit': '1090.00', 'upperLimit': '3220.00'}, {'value': '2355.0', 'groupId': 'OG001', 'lowerLimit': '2210.00', 'upperLimit': '2500.00'}, {'value': '1933.3', 'groupId': 'OG002', 'lowerLimit': '1280.00', 'upperLimit': '3170.00'}, {'value': '1942.5', 'groupId': 'OG003', 'lowerLimit': '1540.00', 'upperLimit': '2420.00'}, {'value': '1620.0', 'groupId': 'OG004', 'lowerLimit': '1290.00', 'upperLimit': '1990.00'}, {'value': '3798.3', 'groupId': 'OG005', 'lowerLimit': '1270.00', 'upperLimit': '11100.00'}, {'value': '2906.9', 'groupId': 'OG006', 'lowerLimit': '2090.00', 'upperLimit': '4020.00'}, {'value': '1637.7', 'groupId': 'OG007', 'lowerLimit': '410.00', 'upperLimit': '2770.00'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3462.5', 'groupId': 'OG000', 'lowerLimit': '2300.00', 'upperLimit': '4210.00'}, {'value': '1500.0', 'groupId': 'OG001', 'lowerLimit': '1500.00', 'upperLimit': '1500.00'}, {'value': '1200.3', 'groupId': 'OG002', 'lowerLimit': '421.00', 'upperLimit': '2090.00'}, {'value': '1550.0', 'groupId': 'OG003', 'lowerLimit': '1550.00', 'upperLimit': '1550.00'}, {'value': '3103.3', 'groupId': 'OG004', 'lowerLimit': '1440.00', 'upperLimit': '4890.00'}, {'value': '1602.3', 'groupId': 'OG005', 'lowerLimit': '597.00', 'upperLimit': '2350.00'}, {'value': '2964.0', 'groupId': 'OG006', 'lowerLimit': '1560.00', 'upperLimit': '4070.00'}, {'value': '1765.7', 'groupId': 'OG007', 'lowerLimit': '654.00', 'upperLimit': '2670.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycles 1 and 2: Day 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Cmin: Minimum Observed Plasma Concentration for Paclitaxel', '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'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the change in planned analysis, minimum plasma concentration data was not collected.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.17'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '1.17'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.15'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.87', 'upperLimit': '1.55'}, {'value': '1.2', 'groupId': 'OG004', 'lowerLimit': '1.08', 'upperLimit': '1.62'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '2.22'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '0.52', 'upperLimit': '1.87'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '1.88'}]}]}, {'title': 'Cycle 2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.47'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.2'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.6'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.20', 'upperLimit': '1.50'}, {'value': '1.2', 'groupId': 'OG004', 'lowerLimit': '1.07', 'upperLimit': '1.75'}, {'value': '1.2', 'groupId': 'OG005', 'lowerLimit': '1.08', 'upperLimit': '1.83'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '0.95', 'upperLimit': '1.17'}, {'value': '1.1', 'groupId': 'OG007', 'lowerLimit': '1.02', 'upperLimit': '1.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycles 1 and 2: Day 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during Dose Escalation phase of study who received at least 1 dose of MLN0128 or paclitaxel and had sufficient concentration-time data to calculate PK parameters for either compound. Here, number analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Terminal Phase Elimination Half-life (T1/2) for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '9.93', 'upperLimit': '10.00'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '8.83', 'upperLimit': '9.48'}, {'value': '9.6', 'groupId': 'OG002', 'lowerLimit': '8.19', 'upperLimit': '11.60'}, {'value': '9.3', 'groupId': 'OG003', 'lowerLimit': '9.10', 'upperLimit': '9.53'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.'}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '4590.0', 'groupId': 'OG000', 'lowerLimit': '3440.00', 'upperLimit': '5740.00'}, {'value': '4790.0', 'groupId': 'OG001', 'lowerLimit': '4040.00', 'upperLimit': '6270.00'}, {'value': '5002.0', 'groupId': 'OG002', 'lowerLimit': '2910.00', 'upperLimit': '6330.00'}, {'value': '5485.0', 'groupId': 'OG003', 'lowerLimit': '4550.00', 'upperLimit': '6420.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.'}, {'type': 'SECONDARY', 'title': 'AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 mg QW', 'description': 'MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG004', 'title': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG005', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG006', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG007', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '3198.3', 'groupId': 'OG000', 'lowerLimit': '1560.00', 'upperLimit': '4140.00'}, {'value': '3515.0', 'groupId': 'OG001', 'lowerLimit': '2930.00', 'upperLimit': '4100.00'}, {'value': '2620.0', 'groupId': 'OG002', 'lowerLimit': '1800.00', 'upperLimit': '3970.00'}, {'value': '3157.5', 'groupId': 'OG003', 'lowerLimit': '2810.00', 'upperLimit': '3550.00'}, {'value': '2683.3', 'groupId': 'OG004', 'lowerLimit': '1820.00', 'upperLimit': '3630.00'}, {'value': '5315.0', 'groupId': 'OG005', 'lowerLimit': '1880.00', 'upperLimit': '15100.00'}, {'value': '3683.8', 'groupId': 'OG006', 'lowerLimit': '2600.00', 'upperLimit': '5330.00'}, {'value': '2657.0', 'groupId': 'OG007', 'lowerLimit': '1140.00', 'upperLimit': '5350.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the PK population, all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters, with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'AUC(0-24): Area Under the Plasma Concentration-time Curve Extrapolated to 24 Hours for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '3583.3', 'groupId': 'OG000', 'lowerLimit': '2510.00', 'upperLimit': '5160.00'}, {'value': '4332.5', 'groupId': 'OG001', 'lowerLimit': '3670.00', 'upperLimit': '5510.00'}, {'value': '6415.0', 'groupId': 'OG002', 'lowerLimit': '2550.00', 'upperLimit': '15900.00'}, {'value': '5135.0', 'groupId': 'OG003', 'lowerLimit': '4290.00', 'upperLimit': '5980.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC0-24 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.'}, {'type': 'SECONDARY', 'title': 'CL: Total Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '24.70', 'upperLimit': '47.70'}, {'value': '34.8', 'groupId': 'OG001', 'lowerLimit': '22.30', 'upperLimit': '45.30'}, {'value': '31.2', 'groupId': 'OG002', 'lowerLimit': '22.30', 'upperLimit': '48.20'}, {'value': '25.8', 'groupId': 'OG003', 'lowerLimit': '19.30', 'upperLimit': '32.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. CL data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.'}, {'type': 'SECONDARY', 'title': 'Vss: Volume of Distribution at Steady State Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG001', 'title': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG002', 'title': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}, {'id': 'OG003', 'title': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established.'}], 'classes': [{'categories': [{'measurements': [{'value': '313.5', 'groupId': 'OG000', 'lowerLimit': '189.00', 'upperLimit': '438.00'}, {'value': '262.0', 'groupId': 'OG001', 'lowerLimit': '219.00', 'upperLimit': '306.00'}, {'value': '252.2', 'groupId': 'OG002', 'lowerLimit': '149.00', 'upperLimit': '441.00'}, {'value': '150.0', 'groupId': 'OG003', 'lowerLimit': '120.00', 'upperLimit': '180.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1', 'unitOfMeasure': 'L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. Vss data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MLN0128P 30 or 40 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).'}, {'id': 'OG001', 'title': 'MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).'}, {'id': 'OG002', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}, {'id': 'OG003', 'title': 'Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).'}, {'id': 'OG004', 'title': 'Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}]}, {'title': 'Fatal AEs within 30 Days of Last Dose Study Drug', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'AEs Resulting in Discontinuation of MLN0128', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated (ASaT) population consisted of all enrolled participants who received at least 1 dose of MLN0128, was used in the safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MLN0128P 30 or 40 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).'}, {'id': 'FG001', 'title': 'MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).'}, {'id': 'FG002', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}, {'id': 'FG003', 'title': 'Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).'}, {'id': 'FG004', 'title': 'Expansion Cohort MLN0128PH 8mg QD×3d QW HER2+ Plus Trastuzumab', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Here, started indicates the participants who were enrolled.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Dose-escalation Evaluable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Enrolled but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at three investigative sites in the United States from 28 February 2011 to 15 Sep 2017.', 'preAssignmentDetails': 'Participants with advanced solid malignancies enrolled in the dose escalation phase to establish MTD: MLN0128 6,7,8,9,10 mg QDx3d QW, 7mg QDx5d QW or 30, 40 mg QW. The expansion phase enrolled participants in either A: HER2- cancer participants, MLN0128 at MTD+paclitaxel or B: HER2+ cancer participants, MLN0128 at MTD+paclitaxel+trastuzumab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'MLN0128P 30 or 40 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 or 40 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until Maximum Tolerated Dose (MTD) was established (Up to 15.3 weeks).'}, {'id': 'BG001', 'title': 'MLN0128P 6, 7, 8, 9 or 10 mg QD×3d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 6 , 7, 8, 9 or 10 mg, capsule, orally, once daily (QD) 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up to 87.4 weeks).'}, {'id': 'BG002', 'title': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase until MTD was established (Up 65.4 weeks).'}, {'id': 'BG003', 'title': 'Expansion Cohort MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 61.6 weeks).'}, {'id': 'BG004', 'title': 'Expansion Cohort MLN0128PH 8mg QDx3d QW HER2+ Plus Trastuzumab', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase (Up to 23.4 weeks).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '14.34', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '9.57', 'groupId': 'BG001'}, {'value': '58.1', 'spread': '14.70', 'groupId': 'BG002'}, {'value': '54.2', 'spread': '14.46', 'groupId': 'BG003'}, {'value': '58.1', 'spread': '8.03', 'groupId': 'BG004'}, {'value': '59.3', 'spread': '12.07', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Subjects as Treated (ASaT) population, which consisted of all enrolled participants who received at least 1 dose of MLN0128.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-10-07', 'size': 560278, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-13T16:37', 'hasProtocol': False}, {'date': '2014-03-05', 'size': 905639, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-13T16:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-28', 'studyFirstSubmitDate': '2011-02-21', 'resultsFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-28', 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation Phase: Maximum Tolerated Dose (MTD)', 'timeFrame': 'Cycle 1: Days 1 to 28', 'description': 'MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.'}, {'measure': 'Dose Escalation Phase: Number of Participants With at Least 1 Dose Limiting Toxicity (DLT)', 'timeFrame': 'Cycle 1: Days 1 to 28', 'description': 'DLT was defined as any of the following occurring during Cycle 1 (Days 1-28) and attributable to MLN0128P: Grade ≥ 3 nonhematologic toxicity; Grade 3 thrombocytopenia with hemorrhage; Grade 4 neutropenia lasting \\> 7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever 38.5 degrees C and/or infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75 % of doses of MLN0128 within Cycle 1 due to drug-related toxicity; Any clinically significant occurrence which the investigators and sponsor agree would place participants at undue safety risk; Participants who experienced an adverse event (AE) that met the definition for a DLT.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'At screening and thereafter every 2 cycles of treatment until disease progression (Up to 65.8 weeks)', 'description': 'ORR was defined as the percentage of participants with Complete Response (CR) and Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Each cycle was a 28 day cycle. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.'}, {'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug', 'timeFrame': 'First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for MLN0128', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.'}, {'measure': 'Cmin: Minimum Observed Plasma Concentration for MLN0128', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.'}, {'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i.e., C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.'}, {'measure': 'Terminal Phase Elimination Half-life (T1/2) for MLN0128', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for MLN0128', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 30 and 40 mg QW arms.'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for Paclitaxel', 'timeFrame': 'Cycles 1 and 2: Day 1'}, {'measure': 'Cmin: Minimum Observed Plasma Concentration for Paclitaxel', 'timeFrame': 'Cycles 1 and 2: Day 1 or 2', 'description': 'Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.'}, {'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Paclitaxel', 'timeFrame': 'Cycles 1 and 2: Day 1'}, {'measure': 'Terminal Phase Elimination Half-life (T1/2) for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'AUC(0-24): Area Under the Plasma Concentration-time Curve Extrapolated to 24 Hours for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'CL: Total Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}, {'measure': 'Vss: Volume of Distribution at Steady State Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel', 'timeFrame': 'Cycle 1 Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid tumor, mTORC1/2 inhibitors, HER2'], 'conditions': ['Advanced Solid Malignancies', 'Hematologic Malignancies']}, 'referencesModule': {'references': [{'pmid': '28601972', 'type': 'DERIVED', 'citation': 'Burris HA 3rd, Kurkjian CD, Hart L, Pant S, Murphy PB, Jones SF, Neuwirth R, Patel CG, Zohren F, Infante JR. TAK-228 (formerly MLN0128), an investigational dual TORC1/2 inhibitor plus paclitaxel, with/without trastuzumab, in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2017 Aug;80(2):261-273. doi: 10.1007/s00280-017-3343-4. Epub 2017 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.', 'detailedDescription': 'This is a Phase I, open-label study consisting of a dose escalation phase in advanced solid malignancies to determine the maximum tolerated dose (MTD) of oral administration of MLN0128 in 1 or more dosing schedules, combined with paclitaxel on Days 1, 8 and 15 of each cycle, followed by an expansion phase for further safety and preliminary efficacy.\n\nOnce the MTD is determined for each of the dosing schedules evaluated, a dose and schedule will be selected for the expansion phase, which may enroll participants into 2 arms in parallel:\n\n* Arm A will consist of HER2- unknown cancer participants receiving MLN0128+paclitaxel\n* Arm B will consist of HER2+ cancer participants receiving MLN0128+paclitaxel plus weekly trastuzumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary written consent\n* Locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Ability to swallow oral medications\n* For women of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to 30 days following the last study drug administration\n* Male participants must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration\n* Clinical laboratory values as specified in the protocol\n* For expansion phase (Arm A) - HER2-/unknown participants will be enrolled\n* For expansion phase (Arm B) - HER2+ cancer participants will be enrolled\n\nExclusion Criteria:\n\n* Diagnosis of primary brain tumor\n* Have received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug\n* Known impaired cardiac function or clinically significant cardiac disease\n* Known treatment with systemic corticosteroid within one week prior to the first administration of study drug\n* Diabetes mellitus\n* Human immunodeficiency virus (HIV) infection\n* Known active cardiovascular disease condition as specified in protocol\n* Pregnancy (positive serum or urine pregnancy test) or breast feeding\n* Malabsorption due to prior gastrointestinal (GI) surgery, GI disease\n* Other clinically significant co-morbidities\n\nPlease note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.\n\nSite personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons'}, 'identificationModule': {'nctId': 'NCT01351350', 'briefTitle': 'Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase I, Open Label, Dose Escalation Study of Oral Administration of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'INK128-003'}, 'secondaryIdInfos': [{'id': 'U1111-1181-8192', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MLN0128P 30 mg QW', 'description': 'MLN0128 and paclitaxel (MLN0128P): MLN0128 30 mg, capsule, orally, once weekly (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 40 mg QW', 'description': 'MLN0128 40 mg, capsule, orally, once a week (QW) + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 6 mg QD×3d QW', 'description': 'MLN0128 6 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 7 mg QD×3d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 8 mg QD×3d QW', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 9 mg QD×3d QW', 'description': 'MLN0128 9 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 10 mg QD×3d QW', 'description': 'MLN0128 10 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 7 mg QD×5d QW', 'description': 'MLN0128 7 mg, capsule, orally, once daily 5 days on/2 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in the Dose Escalation Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128P 8 mg QD×3d QW HER2-', 'description': 'MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 of a 4-week cycle in human epidermal growth factor receptor 2 negative (HER-) cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'MLN0128PH 8 mg QD×3d QW HER2+', 'description': 'MLN0128 + paclitaxel + trastuzumab (MLN0128PH): MLN0128 8 mg, capsule, orally, once daily 3 days on/4 days off each week + paclitaxel 80 mg/m\\^2, 1 hour infusion, on Days 1, 8 and 15 plus trastuzumab 4 mg/kg loading dose on Day 1 followed by 2 mg/kg, intravenous each week of a 4-week cycle in HER+ cancer participants until disease progression or unacceptable toxicity for up to 1 year in the Expansion Phase.', 'interventionNames': ['Drug: MLN0128', 'Drug: paclitaxel', 'Drug: trastuzumab']}], 'interventions': [{'name': 'MLN0128', 'type': 'DRUG', 'description': 'MLN0128 capsules', 'armGroupLabels': ['MLN0128P 10 mg QD×3d QW', 'MLN0128P 30 mg QW', 'MLN0128P 40 mg QW', 'MLN0128P 6 mg QD×3d QW', 'MLN0128P 7 mg QD×3d QW', 'MLN0128P 7 mg QD×5d QW', 'MLN0128P 8 mg QD×3d QW', 'MLN0128P 8 mg QD×3d QW HER2-', 'MLN0128P 9 mg QD×3d QW', 'MLN0128PH 8 mg QD×3d QW HER2+']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'paclitaxel intravenous infusion', 'armGroupLabels': ['MLN0128P 10 mg QD×3d QW', 'MLN0128P 30 mg QW', 'MLN0128P 40 mg QW', 'MLN0128P 6 mg QD×3d QW', 'MLN0128P 7 mg QD×3d QW', 'MLN0128P 7 mg QD×5d QW', 'MLN0128P 8 mg QD×3d QW', 'MLN0128P 8 mg QD×3d QW HER2-', 'MLN0128P 9 mg QD×3d QW', 'MLN0128PH 8 mg QD×3d QW HER2+']}, {'name': 'trastuzumab', 'type': 'DRUG', 'description': 'trastuzumab intravenous infusion', 'armGroupLabels': ['MLN0128PH 8 mg QD×3d QW HER2+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33905', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}