Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxe... | NCT01862328 | Trialant
NCT01862328
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Jun 22, 2020Actual
Enrollment
64Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
MLN4924
Paclitaxel
Gemcitabine
Docetaxel
Carboplatin
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01862328
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C15010
Secondary IDs
ID
Type
Description
Link
U1111-1220-1470
Other Identifier
WHO
Brief Title
Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors
Official Title
A Phase 1b, Open-Label, Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Patients With Solid Tumors
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 10, 2013Actual
Primary Completion Date
May 21, 2018Actual
Completion Date
May 21, 2018Actual
First Submitted Date
May 15, 2013
First Submission Date that Met QC Criteria
May 22, 2013
First Posted Date
May 24, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 4, 2019
Results First Submitted that Met QC Criteria
Jun 5, 2020
Results First Posted Date
Jun 22, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 5, 2020
Last Update Posted Date
Jun 22, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Millennium Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to establish the maximum tolerated dose (MTD) and assess the safety and tolerability of MLN4924 (pevonedistat) in combination with docetaxel, paclitaxel and carboplatin, and gemcitabine in participants with solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
MLN4924
Solid Tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
64Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MLN4924 and Docetaxel (Arm 1)
Experimental
Drug: MLN4924
Drug: Docetaxel
MLN4924 + Paclitaxel + Carboplatin (Arm 2)
Experimental
Drug: MLN4924
Drug: Paclitaxel
Drug: Carboplatin
MLN4924 + Gemcitabine (Arm 3)
Experimental
Drug: MLN4924
Drug: Gemcitabine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MLN4924
Drug
MLN4924 (intravenously [IV]) in participants in a 21-day cycle:
MLN4924 on Days 1,3,5 of each cycle
MLN4924 + Gemcitabine (Arm 3)
MLN4924 + Paclitaxel + Carboplatin (Arm 2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline up to 30 days after the last dose of study drug (up to 5 years)
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings
Baseline up to 30 days after the last dose of study drug (up to 5 years)
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings
Baseline up to 30 days after the last dose of study drug (up to 5 years)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Objective Response
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]); no new lesions. PR: greater than or equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with 1 of the 3 chemotherapy regimens in this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable
Recovered (that is, <=Grade 1 toxicity) from the effects of prior antineoplastic therapy
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence
Male participants who agree to practice effective barrier contraception or agree to practice true abstinence
Voluntary written consent must be given before performance of any study-related procedure
Suitable venous access for the study-required blood sampling
Adequate clinical laboratory values during the screening period as specified in the protocol
Participants who are willing to refrain from donating blood for at least 90 days after their final dose of MLN4924 and (for male participants) willing to refrain from donating semen for at least 4 months after their final dose of MLN4924
Availability of fixed tumor specimen (block or slides) for exploratory biomarker analysis. If no slides or block are available, fresh tumor biopsies should be obtained and used for these assessments
Exclusion Criteria:
Major surgery within 14 days before the first dose of study drug
Female participants who are lactating or pregnant
Active uncontrolled infection or severe infectious disease
Receiving antibiotic therapy within 14 days before the first dose of study treatment
Life-threatening illness unrelated to cancer
Known hypersensitivity to study-assigned chemotherapy
Prior treatment with MLN4924; however, prior treatment with docetaxel, paclitaxel,carboplatin, and gemcitabine is allowed
History of severe hypersensitivity reactions to docetaxel (polysorbate 80-based formulations) for participants to be enrolled in Arm 1 (MLN4924 + docetaxel), history of hypersensitivity to carboplatin for participants to be enrolled in Arm 2 (MLN4924 + paclitaxel + carboplatin), or history of severe hypersensitivity to paclitaxel (cremophor-based formulations) for participants to be enrolled in Arm 2
Persistent diarrhea (greater than Grade 2) lasting >3 days within 2 weeks before the first dose of study treatment
Systemic antineoplastic therapy within 21 days before the first dose of study drug
Radiotherapy within 14 days preceding the first dose of study treatment
Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of the hematopoietically active bone marrow
Treatment with cytochrome P450 3A (CYP3A) inducers within 14 days before the first dose of MLN4924.
Treatment with CYP3A inhibitors within 14 days before the first dose of MLN4924; however, voriconazole and fluconazole need only be stopped for 3 days before MLN4924. Participants must have no history of amiodarone use in the 6 months before the first dose of MLN4924 14. Clinically uncontrolled central nervous system (CNS) involvement 15. Any serious medical or psychiatric illness 16. Treatment with any investigational products 21 days prior to treatment 17. Unwilling or unable to refrain from using statins 24 hours before, the day of, and 24 hours after each MLN4924 administration 18. Known human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection 19. Known hepatic cirrhosis 20. Known cardiac/cardiopulmonary disease 21. Left ventricular ejection fraction 23. with a cardiac pacer whose heart rate is set at a fixed rate and participants on concomitant medication that may limit increase in heart rate in response to hypotension 24 History of severe intolerance to cytotoxic agent(s) given in the assigned arm
Faessel HM, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies. Br J Clin Pharmacol. 2019 Nov;85(11):2568-2579. doi: 10.1111/bcp.14078. Epub 2019 Sep 4.
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants with solid tumors were enrolled to receive MLN4924 in combination with docetaxel (Arm 1), paclitaxel + carboplatin (Arm 2), or gemcitabine (Arm 3) during the Dose-escalation and maximum tolerated dose (MTD) expansion portion of this study. Participants in Lead-in cohort received MLN4924 + carboplatin only (Arm 2a).
Recruitment Details
Participants took part in the study at 6 investigative sites in the United States from 10 June 2013 to 21 May 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or progressive disease (PD) (up to Cycle 52).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Mar 22, 2016
Nov 4, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MLN4924 and Docetaxel (Arm 1)
Pevonedistat
Paclitaxel
Drug
Paclitaxel (IV) in a 21-day cycle:
Paclitaxel on Day 1 of each cycle
MLN4924 + Paclitaxel + Carboplatin (Arm 2)
Gemcitabine
Drug
Gemcitabine (IV) in participants in a 28-day cycle:
-Gemcitabine on Days 1,8,15 of each cycle
MLN4924 + Gemcitabine (Arm 3)
Docetaxel
Drug
Docetaxel (IV) in participants in a 21-day cycle:
- Docetaxel on Day 1 of each cycle
MLN4924 and Docetaxel (Arm 1)
Carboplatin
Drug
Carboplatin (IV) in participants in a 21-day cycle:
- Carboplatin on Day 1 of each cycle
MLN4924 + Paclitaxel + Carboplatin (Arm 2)
Screening, Cycle 2 Days 15 (Arm 1, 2a, and 2) and 22 (Arm 3) then every other Cycle thereafter up to 30 days after the last dose of study drug (up to 5 years) (Cycle Length = 21 days [Arm 1, 2a, and 2] and 28 days [Arm 3])
Duration of Response
Duration of response: time from the date of first documented response per the investigator response assessment (CR or PR) to the date of PD or the date of last disease assessment if the participant discontinued the study before PD using RECIST 1.1 CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in sum of diameters of target lesions, taking as reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
From the date of first documented response (CR or PR) to the date of first documented PD or the date of last disease assessment if the participants discontinued the study before PD (up to 5 years)
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924
Cycle 1 Day 1 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2] and 28 days [Arm 3])
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924
The number of participants analyzed includes only those participants who had data available for this measure.
Cycle 1 Days 1 and 5 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2])
St Louis
Missouri
63110
United States
Chapel Hill
North Carolina
27599
United States
Cleveland
Ohio
44106-4948
United States
Philadelphia
Pennsylvania
19104
United States
Nashville
Tennessee
37203
United States
Lockhart AC, Bauer TM, Aggarwal C, Lee CB, Harvey RD, Cohen RB, Sedarati F, Nip TK, Faessel H, Dash AB, Dezube BJ, Faller DV, Dowlati A. Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumors. Invest New Drugs. 2019 Feb;37(1):87-97. doi: 10.1007/s10637-018-0610-0. Epub 2018 May 21.
FG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
FG0004 subjects
FG00118 subjects
FG0026 subjects
FG0037 subjects
FG00412 subjects
FG0057 subjects
FG00610 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0004 subjects
FG00118 subjects
FG0026 subjects
FG0037 subjects
FG00412 subjects
FG0057 subjects
FG00610 subjects
Type
Comment
Reasons
Progressive Disease
FG0003 subjects
FG00111 subjects
FG0025 subjects
FG0036 subjects
FG0047 subjects
FG0054 subjects
FG0063 subjects
Adverse Event
FG0000 subjects
FG0014 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Symptomatic Deterioration
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety population was defined as all participants who received at least 1 dose of any study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00118
BG0026
BG0037
BG00412
BG0057
BG00610
BG00764
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00057.8± 2.99
BG00160.0± 9.82
BG00256.8± 9.56
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG00111
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG00118
BG002
Body surface area (BSA)
Mean
Standard Deviation
square meter (m^2)
Title
Denominators
Categories
Title
Measurements
BG0001.9± 0.32
BG0011.9± 0.28
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The safety population was defined as all participants who received at least 1 dose of any study drug.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (up to 5 years)
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Units
Counts
Participants
OG0004
OG00118
OG0026
OG003
Title
Denominators
Categories
TEAE
Title
Measurements
OG0004
OG00118
OG0026
OG003
Primary
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings
The safety population was defined as all participants who received at least 1 dose of any study drug.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (up to 5 years)
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Primary
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings
The safety population was defined as all participants who received at least 1 dose of any study drug.
Posted
Count of Participants
Participants
Baseline up to 30 days after the last dose of study drug (up to 5 years)
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Secondary
Percentage of Participants With Objective Response
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]); no new lesions. PR: greater than or equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
The response-evaluable population was defined as all the participants who received at least 1 dose of MLN4924, had measurable disease at baseline, and had at least 1 post baseline disease assessment.
Posted
Number
percentage of participants
Screening, Cycle 2 Days 15 (Arm 1, 2a, and 2) and 22 (Arm 3) then every other Cycle thereafter up to 30 days after the last dose of study drug (up to 5 years) (Cycle Length = 21 days [Arm 1, 2a, and 2] and 28 days [Arm 3])
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Secondary
Duration of Response
Duration of response: time from the date of first documented response per the investigator response assessment (CR or PR) to the date of PD or the date of last disease assessment if the participant discontinued the study before PD using RECIST 1.1 CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of sum of diameters of all target lesions; short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in sum of diameters of target lesions, taking as reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
The response-evaluable population is defined as all participants who receive at least 1 dose of study drug, have measurable disease at baseline, and have at least 1 post baseline disease assessment. The number of participants analyzed includes only those participants who had data available for this measure.
Posted
Mean
Standard Deviation
months
From the date of first documented response (CR or PR) to the date of first documented PD or the date of last disease assessment if the participants discontinued the study before PD (up to 5 years)
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Secondary
Dose-escalation Phase: Plasma Concentrations-time Data of MLN4924
The safety population was defined as all participants who received at least 1 dose of any study drug. The number of participants analyzed includes only those participants who had data available for this measure. This outcome measure was planned to be assessed only in the Dose-escalation phases of Arms 1, 2, and 3.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/ml)
Cycle 1 Day 1 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2] and 28 days [Arm 3])
ID
Title
Description
OG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
Secondary
MTD Expansion Phase: Plasma Concentrations-time Data of MLN4924
The number of participants analyzed includes only those participants who had data available for this measure.
The safety population was defined as all participants who received at least 1 dose of any study drug. This outcome measure was planned to be assessed for participants who received the MTD in Arms 1 and 2.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1 Days 1 and 5 pre-dose and at multiple time points (up to 20 hours) post-dose (Cycle Length=21 days [Arm 1 and 2])
ID
Title
Description
OG000
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG001
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Time Frame
TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (up to 5 years) after the last dose of study drug
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1: MLN4924 15 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 15 milligram per square meter (mg/m^2), infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
0
4
1
4
4
4
EG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
2
18
9
18
18
18
EG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
0
6
3
6
6
6
EG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
0
7
2
7
6
7
EG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
0
12
3
12
12
12
EG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
1
7
1
7
7
7
EG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
3
10
7
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG0031 affected7 at risk
EG0041 affected12 at risk
EG0050 affected7 at risk
EG0062 affected10 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Death
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram ST segment depression
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Liver function test increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Malignant neoplasm of unknown primary site
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0016 affected18 at risk
EG0023 affected6 at risk
EG0032 affected7 at risk
EG0048 affected12 at risk
EG0052 affected7 at risk
EG0064 affected10 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0023 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0021 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0018 affected18 at risk
EG0025 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected18 at risk
EG0024 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected4 at risk
EG0016 affected18 at risk
EG0021 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0014 affected18 at risk
EG0021 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0014 affected18 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0021 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0015 affected18 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0022 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG00111 affected18 at risk
EG0024 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected18 at risk
EG0021 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0021 affected6 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0022 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0016 affected18 at risk
EG0022 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0017 affected18 at risk
EG0021 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected18 at risk
EG0021 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0022 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected18 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0022 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0022 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected18 at risk
EG0021 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0022 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0021 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0021 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0023 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0022 affected6 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0002 affected4 at risk
EG0011 affected18 at risk
EG0023 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 affected4 at risk
EG0011 affected18 at risk
EG0022 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0021 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected18 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0014 affected18 at risk
EG0021 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected18 at risk
EG0021 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected18 at risk
EG0020 affected6 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected18 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected18 at risk
EG0022 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected18 at risk
EG0022 affected6 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Eye irritation
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0022 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Localised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0022 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Testicular appendage torsion
Reproductive system and breast disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0021 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Uraemic encephalopathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Platelet count increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected18 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Units
Counts
Participants
OG0004
OG00118
OG0026
OG0037
OG00412
OG0057
OG00610
Title
Denominators
Categories
Anaemia
Title
Measurements
OG0001
OG0014
OG0022
OG0032
OG0047
OG0052
OG0063
Aspartate aminotransferase increased
Title
Measurements
OG0000
OG0016
OG0022
OG003
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0017
OG0021
OG003
Neutrophil count decreased
Title
Measurements
OG0001
OG0015
OG0021
OG003
Neutropenia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Thrombocytopenia
Title
Measurements
OG0000
OG0011
OG0023
OG003
Platelet count decreased
Title
Measurements
OG0000
OG0011
OG0022
OG003
White blood cell count decreased
Title
Measurements
OG0001
OG0012
OG0020
OG003
Hypomagnesaemia
Title
Measurements
OG0000
OG0012
OG0022
OG003
Blood creatinine increased
Title
Measurements
OG0001
OG0012
OG0020
OG003
Blood alkaline phosphatase increased
Title
Measurements
OG0000
OG0012
OG0020
OG003
Lymphocyte count decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood bilirubin increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypophosphataemia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Hypokalaemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Gamma-glutamyltransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Blood glucose increased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Liver function test abnormal
Title
Measurements
OG0000
OG0011
OG0020
OG003
Haematocrit decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Red blood cell count decreased
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hypoglycaemia
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hyponatraemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Units
Counts
Participants
OG0004
OG00118
OG0026
OG0037
OG00412
OG0057
OG00610
Title
Denominators
Categories
Tachycardia
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0040
OG0050
OG0060
Hypotension
Title
Measurements
OG0001
OG0013
OG0022
OG003
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Units
Counts
Participants
OG0003
OG00116
OG0026
OG0037
OG00411
OG0055
OG0066
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG00418
OG0050
OG0060
PR
Title
Measurements
OG0000
OG00119
OG00217
OG003
OG001
Arm 1: MLN4924 25 mg/m^2 + Docetaxel 75 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and docetaxel 75 mg/m^2, infusion, intravenously, once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG002
Arm 2a: MLN4924 15 mg/m^2 + Carboplatin AUC6
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and carboplatin AUC6, infusion intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG003
Arm 2: MLN4924 15 mg/m^2+Paclitaxel 175mg/m^2+Carboplatin AUC5
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG006
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
Units
Counts
Participants
OG0000
OG0013
OG0021
OG0030
OG0046
OG0052
OG0060
Title
Denominators
Categories
Title
Measurements
OG0012.880± 2.7644
OG0022.270± NAStandard deviation could not be calculated since only one participant was available for analysis.
OG00416.153± 15.9867
OG0057.015± 1.1384
MLN4924 15 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG003
Arm 2:MLN4924 20 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 20 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5, infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG004
Arm 2:MLN4924 25 mg/m^2+Paclitaxel 175 mg/m^2+Carboplatin AUC5
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 3, and 5 and paclitaxel 175 mg/m^2, infusion, intravenously, once on Day 1 followed by carboplatin AUC5 infusion, intravenously once on Day 1 before administration of MLN4924 in a 21-day cycle up to symptomatic deterioration or PD (up to Cycle 52).
OG005
Arm 3: MLN4924 25 mg/m^2 + Gemcitabine 1000 mg/m^2
MLN4924 25 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 and gemcitabine 1000 mg/m^2, infusion, intravenously, once on Days 1, 8, and 15 before administration of MLN4924 in a 28-day cycle up to symptomatic deterioration or PD (up to Cycle 52).