Trial Outcomes & Findings for Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older (NCT NCT01814826)

NCT ID: NCT01814826

Last Updated: 2020-03-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

Baseline up to 30 days after the last dose of study drug (up to 5 years)

Results posted on

2020-03-03

Participant Flow

Participants took part in the study at 8 investigative sites in the United states from 10 April 2013 to 08 April 2018.

Participants diagnosed with acute myelogenous leukemia (AML) were enrolled to receive MLN4924 in combination with azacitidine intravenous during dose-escalation phase and MLN4924 in combination with azacitidine intravenous or subcutaneous during expansion phase.

Participant milestones

Participant milestones
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Overall Study STARTED	32	29	3
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	32	29	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Overall Study Other	3	5	0
Overall Study Death	29	24	3

Baseline Characteristics

Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	Total n=64 Participants Total of all reporting groups
Age, Continuous	74.7 years STANDARD_DEVIATION 6.28 • n=5 Participants	75.2 years STANDARD_DEVIATION 6.00 • n=7 Participants	80.3 years STANDARD_DEVIATION 3.21 • n=5 Participants	75.2 years STANDARD_DEVIATION 6.09 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	2 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	1 Participants n=5 Participants	34 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	22 Participants n=7 Participants	3 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	28 Participants n=7 Participants	3 Participants n=5 Participants	58 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	32 Participants n=5 Participants	29 Participants n=7 Participants	3 Participants n=5 Participants	64 Participants n=4 Participants
Body Surface Area (BSA)	1.88 square meter (m^2) STANDARD_DEVIATION 0.249 • n=5 Participants	1.85 square meter (m^2) STANDARD_DEVIATION 0.256 • n=7 Participants	1.79 square meter (m^2) STANDARD_DEVIATION 0.428 • n=5 Participants	1.86 square meter (m^2) STANDARD_DEVIATION 0.257 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	32 Participants	29 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	21 Participants	22 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood creatinine increased	6 Participants	3 Participants	2 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Proteinuria	1 Participants	0 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood urea increased	1 Participants	1 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Renal impairment	0 Participants	1 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood bilirubin increased	3 Participants	1 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Aspartate aminotransferase increased	5 Participants	2 Participants	2 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Alanine aminotransferase increased	6 Participants	3 Participants	2 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Gamma-glutamyltransferase increased	1 Participants	2 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Blood alkaline phosphatase increased	7 Participants	0 Participants	2 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Anaemia	15 Participants	10 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Neutropenia	10 Participants	6 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Leukopenia	5 Participants	2 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Febrile neutropenia	7 Participants	12 Participants	1 Participants
Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings Neutrophil count decreased	6 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to 5 years)

Population: The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings Tachycardia	4 Participants	1 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings Hypotension	3 Participants	6 Participants	0 Participants
Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings Orthostatic Hypotension	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length is equal to [=] 28 days)

Population: The pharmacokinetic (PK)-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924 Cycle 1 Day 1	173.60 nanogram per milliliter (ng/mL) Standard Deviation 78.017	306.67 nanogram per milliliter (ng/mL) Standard Deviation 81.304	—
Dose-escalation Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924 Cycle 1 Day 5	177.87 nanogram per milliliter (ng/mL) Standard Deviation 67.767	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Population: The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Maximum Tolerated Dose (MTD) Expansion Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924 Cycle 1 Day 1	168.80 ng/mL Standard Deviation 80.504	159.78 ng/mL Standard Deviation 57.755	—
Maximum Tolerated Dose (MTD) Expansion Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924 Cycle 1 Day 5	176.65 ng/mL Standard Deviation 76.628	158.95 ng/mL Standard Deviation 60.807	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924 Cycle 1 Day 1	1.06 hour Interval 1.0 to 2.3	1.0 hour Interval 1.0 to 1.0	—
Dose-escalation Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924 Cycle Day 5	1.0 hour Interval 1.0 to 1.5	NA hour Interval 1.0 to 1.0 Median could not be calculated since only 1 participant was available for analysis.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924 Cycle 1 Day 1	1.01 hour Interval 0.7 to 2.0	1.00 hour Interval 0.9 to 3.0	—
MTD Expansion Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924 Cycle 1 Day 5	1.0 hour Interval 0.9 to 2.0	0.98 hour Interval 0.8 to 2.0	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924 Cycle 1 Day 1	2.34 ng/mL Standard Deviation 1.987	1.68 ng/mL Standard Deviation 0.450	—
Dose-escalation Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924 Cycle 1 Day 5	1.40 ng/mL Standard Deviation 0.208	NA ng/mL Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924 Cycle 1 Day 1	0.87 ng/mL Standard Deviation 0.974	0.91 ng/mL Standard Deviation 1.105	—
MTD Expansion Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924 Cycle 1 Day 5	1.51 ng/mL Standard Deviation 1.321	1.30 ng/mL Standard Deviation 1.010	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924 Cycle 1 Day 1	1151.20 hournanogram per milliliter (hrng/mL) Standard Deviation 327.445	1805.47 hournanogram per milliliter (hrng/mL) Standard Deviation 423.488	—
Dose-escalation Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924 Cycle 1 Day 5	1139.67 hournanogram per milliliter (hrng/mL) Standard Deviation 351.423	NA hournanogram per milliliter (hrng/mL) Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924 Cycle 1 Day 1	NA hr*ng/mL Standard Deviation NA Mean and standard deviation could not be evaluated since greater than 50% of concentrations at a given time point were not quantifiable or reportable.	NA hr*ng/mL Standard Deviation NA Mean and standard deviation could not be evaluated since greater than 50% of concentrations at a given time point were not quantifiable or reportable.	—
MTD Expansion Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924 Cycle 1 Day 5	1125.90 hr*ng/mL Standard Deviation 276.604	1122.91 hr*ng/mL Standard Deviation 244.752	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924 Cycle 1 Day 1	1020.32 hr*ng/mL Standard Deviation 267.958	1675.41 hr*ng/mL Standard Deviation 398.425	—
Dose-escalation Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924 Cycle 1 Day 5	1039.54 hr*ng/mL Standard Deviation 342.330	NA hr*ng/mL Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924 Cycle 1 Day 1	891.89 hr*ng/mL Standard Deviation 261.82	926.74 hr*ng/mL Standard Deviation 280.128	—
MTD Expansion Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924 Cycle 1 Day 5	946.91 hr*ng/mL Standard Deviation 244.081	954.07 hr*ng/mL Standard Deviation 240.098	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, AUCinf: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity for MLN4924 Cycle 1 Day 1	1101.81 hr*ng/mL Standard Deviation 310.114	1823.68 hr*ng/mL Standard Deviation 420.948	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, AUCinf: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity for MLN4924 Cycle 1 Day 1	990.58 hr*ng/mL Standard Deviation 279.282	1026.45 hr*ng/mL Standard Deviation 310.47	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924 Cycle 1 Day 1	0.09 1 per hour (1/hr) Standard Deviation 0.013	0.09 1 per hour (1/hr) Standard Deviation 0.009	—
Dose-escalation Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924 Cycle 1 Day 5	0.09 1 per hour (1/hr) Standard Deviation 0.009	NA 1 per hour (1/hr) Standard Deviation NA Mean and Standard deviation could not be evaluated since only one participant was analyzed.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924 Cycle 1 Day 1	0.10 1/hr Standard Deviation 0.027	0.10 1/hr Standard Deviation 0.022	—
MTD Expansion Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924 Cycle 1 Day 5	0.09 1/hr Standard Deviation 0.028	0.09 1/hr Standard Deviation 0.022	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924 Cycle 1 Day 1	7.80 hour Standard Deviation 1.126	7.39 hour Standard Deviation 0.699	—
Dose-escalation Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924 Cycle 1 Day 5	7.98 hour Standard Deviation 0.818	NA hour Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924 Cycle 1 Day 1	7.45 hour Standard Deviation 1.851	7.30 hour Standard Deviation 1.762	—
MTD Expansion Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924 Cycle 1 Day 5	8.07 hour Standard Deviation 2.414	7.89 hour Standard Deviation 1.764	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Rac: Observed Accumulation Ratio for MLN4924 Cycle 1 Day 5	0.99 ratio Standard Deviation 0.145	NA ratio Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, Rac: Observed Accumulation Ratio for MLN4924 Cycle 1 Day 5	NA ratio Standard Deviation NA Mean and standard deviation could not be evaluated since greater than 50% of concentrations at a given time point were not quantifiable or reportable.	NA ratio Standard Deviation NA Mean and standard deviation could not be evaluated since greater than 50% of concentrations at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, CLp: Systemic Clearance for MLN4924 Cycle 1 Day 1	35.69 liter per hour (L/hr) Standard Deviation 10.318	29.78 liter per hour (L/hr) Standard Deviation 7.511	—
Dose-escalation Phase, CLp: Systemic Clearance for MLN4924 Cycle 1 Day 5	35.27 liter per hour (L/hr) Standard Deviation 13.701	NA liter per hour (L/hr) Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, CLp: Systemic Clearance for MLN4924 Cycle 1 Day 1	41.35 L/hr Standard Deviation 13.924	39.20 L/hr Standard Deviation 14.191	—
MTD Expansion Phase, CLp: Systemic Clearance for MLN4924 Cycle 1 Day 5	38.10 L/hr Standard Deviation 12.407	34.02 L/hr Standard Deviation 10.010	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=6 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=3 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Dose-escalation Phase, Vss: Volume of Distribution at Steady-state for MLN4924 Cycle 1 Day 1	352.06 liter (L) Standard Deviation 148.987	257.32 liter (L) Standard Deviation 88.354	—
Dose-escalation Phase, Vss: Volume of Distribution at Steady-state for MLN4924 Cycle 1 Day 5	351.82 liter (L) Standard Deviation 182.744	NA liter (L) Standard Deviation NA Mean and Standard deviation could not be evaluated since greater than 50% of the concentration at a given time point were not quantifiable or reportable.	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=26 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
MTD Expansion Phase, Vss: Volume of Distribution at Steady-state for MLN4924 Cycle 1 Day 1	370.53 liter Standard Deviation 141.396	348.66 liter Standard Deviation 128.661	—
MTD Expansion Phase, Vss: Volume of Distribution at Steady-state for MLN4924 Cycle 1 Day 5	401.41 liter Standard Deviation 173.087	370.97 liter Standard Deviation 175.097	—

SECONDARY outcome

Timeframe: Cycle(C)1Day(D)22 and at C2 between D20 and 28 and at C4 and beyond C4 after completion of every 3rd C between D15 and 28 up to 30 days after last dose of study drug/before start of subsequent antineoplastic therapy, if that occurred sooner(up to 5 years)

Population: The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Participants who were evaluable at a particular time point for this outcome measure were included in the assessment.

Disease response was based on best overall response as determined by an investigator based on revised recommendations of the International Working Group (IWG) Response Criteria for AML. Best overall response rate was defined as percentage of participants who had complete response (CR), partial response (PR), or CR/remission with incomplete blood count recovery (Cri). CR: free of leukemia-related symptoms, absolute neutrophil count (ANC) greater than (\>)1.0\*10\^9 per liter (/L), platelet count greater than or equal to (\>=) 100\*10\^9/L, normal bone marrow with \<5 percent (%) blasts and no Auer rods. CRi: As per CR but with residual thrombocytopenia (platelet count \<100\*10\^9/L) or residual neutropenia (ANC \<1.0\*10\^9/L). PR: \>=50% decrease bone marrow blasts to 5 to 25% abnormal cells, or CR with less than or equal to (\<=) 5% blasts if Auer rods present.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=28 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=24 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=2 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Best Overall Response Rate CRi	4 percentage of participants	13 percentage of participants	0 percentage of participants
Best Overall Response Rate CR	43 percentage of participants	33 percentage of participants	50 percentage of participants
Best Overall Response Rate PR	14 percentage of participants	13 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: From the date of first documented CR, PR or CRi up to the date of first disease progression (Up to 5 years)

The duration of response was defined in participants with disease response (CR, CRi, or PR) as the time between the first documentation of response and disease progression. Duration of response was determined by an investigator based on revised recommendations of the IWG Response Criteria for AML. CR: free of leukemia-related symptoms, absolute neutrophil count (ANC) greater than (\>)1.0\*10\^9 per liter (/L), platelet count greater than or equal to (\>=) 100\*10\^9/L, normal bone marrow with \<5 percent (%) blasts and no Auer rods. CRi: As per CR but with residual thrombocytopenia (platelet count \<100\*10\^9/L) or residual neutropenia (ANC \<1.0\*10\^9/L). PR: \>=50% decrease bone marrow blasts to 5 to 25% abnormal cells, or CR with less than or equal to (\<=) 5% blasts if Auer rods present.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=17 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=13 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Duration of Response	9.0 months Interval 5.52 to 15.54	6.0 months Interval 2.0 to 14.16	—

SECONDARY outcome

Timeframe: From the first dose of study drug up to date of death (up to 5 years)

Population: The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.

Overall survival was defined as the time from the first dose of study drug to the date of death. The Kaplan-Meier method was used to estimate overall survival, along with the corresponding 95% confidence interval.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Overall Survival	12.25 months Interval 4.53 to 17.12	4.93 months Interval 3.22 to 14.42	5.22 months Interval 3.38 to 10.71

SECONDARY outcome

Timeframe: 30 days after the first dose of study drug in Cycle 1 (Cycle Length=28 days)

Population: The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.

Outcome measures

Outcome measures
Measure	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=32 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or progressive disease (PD), or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous n=29 Participants MLN4924 20 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, subcutaneously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).	MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous n=3 Participants MLN4924 30 mg/m\^2, infusion, intravenously, once on Days 1, 3, and 5 in combination with azacitidine 75 mg/m\^2, infusion, intravenously, once on Days 1 through 5, 8 and 9 before administration of MLN4924 in a 28-day treatment cycle up to symptomatic deterioration or PD, or until treatment was discontinued for another reason (up to Cycle 53).
Thirty-day Mortality Rate	5 percentage of participants	6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 60 days after the first dose of study drug on Cycle 1 (Cycle Length=28 days)

Population: No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.

Outcome measures

Outcome data not reported

Adverse Events

MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous

Serious events: 21 serious events

Other events: 32 other events

Deaths: 29 deaths

MLN4924 20 mg/m^2 + Azacitidine 75 mg/m^2 Subcutaneous

Serious events: 22 serious events

Other events: 29 other events

Deaths: 24 deaths

MLN4924 30 mg/m^2 + Azacitidine 75 mg/m^2 Intravenous

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Medical director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER