Dose Escalation Study of TAK-117 (MLN1117) in Subjects Wi... | NCT01449370

Dose Escalation Study of TAK-117 (MLN1117) in Subjects Wi... | NCT01449370 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	TAK-117 administered once a day orally	Drug: TAK-117
Arm B	Experimental	TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week	Drug: TAK-117
Arm C	Experimental	TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week	Drug: TAK-117

Name	Type	Description	Arm Group Labels	Other Names
TAK-117	Drug	oral administration of TAK-117, daily and intermittent schedules.	Arm A Arm B Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD) of TAK-117	MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for >14 days. Grade 3: nausea and/or vomiting/diarrhea for >7 days; rash for >7 days; thrombocytopenia with bleeding; fasting hyperglycemia for >24 hours(hr). Grade >=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count <=0.5*10^9per liter[/L]) for >7 days in absence of growth factor support; neutropenia of any duration accompanied with fever >=38.5 degree Celsius and/or systemic infection. Grade >=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.	Baseline up to Cycle 1 Day 21
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1		Baseline up to Cycle 27 Day 45
Number of Participants With Highest Level of TEAEs Severity	Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).	Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Laboratory Values		Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Vital Signs		Baseline up to Cycle 27 day 45

Secondary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study
Subjects must have documented disease progression prior to enrolling into the study
locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy.
Age greater than or equal to (>=) 18 years, including males and females;
Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
Adequate organ function;
Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
Ability to swallow oral medications;
Ability to understand and willingness to sign informed consent prior to initiation of any study procedures;
For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration

Exclusion Criteria:

Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
Have received a systemic corticosteroid within one week prior to the first administration of study drug;
Clinically significant cardiac disease;
Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug;
Malabsorption ;
Poorly controlled diabetes mellitus;
Pregnancy (positive serum or urine pregnancy test) or breast feeding;
Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
Failed to recover from the reversible effects of prior anticancer therapies;
Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha) inhibitor
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
Known human immunodeficiency virus (HIV) infection
Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Millennium Pharmaceuticals, Inc.	Study Director

Arm/Group Information

ID	Title	Description
FG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
FG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
FG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
FG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
FG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
FG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
FG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0028 subjects FG0034 subjects FG0043 subjects FG0053 subjects FG0063 subjects FG0073 subjects FG00812 subjects FG0093 subjects FG0103 subjects FG0113 subjects FG0123 subjects FG01311 subjects FG0143 subjects FG0153 subjects FG0167 subjects FG0173 subjects FG0183 subjects FG0193 subjects FG0206 subjects FG0214 subjects FG0224 subjects FG02310 subjects FG0248 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0006 subjects FG0016 subjects FG0028 subjects FG0034 subjects FG004

Type	Comment	Reasons
Disease Progression		FG0005 subjects FG0014 subjects FG0028 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
BG001	Process A: TAK-117 150 mg, QD

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Maximum Tolerated Dose (MTD) of TAK-117

MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for >14 days. Grade 3: nausea and/or vomiting/diarrhea for >7 days; rash for >7 days; thrombocytopenia with bleeding; fasting hyperglycemia for >24 hours(hr). Grade >=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count <=0.5*10^9per liter[/L]) for >7 days in absence of growth factor support; neutropenia of any duration accompanied with fever >=38.5 degree Celsius and/or systemic infection. Grade >=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

Baseline up to Cycle 1 Day 21

Adverse Events Module

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	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Medical Director	Takeda	+1-877-825-3327		trialdisclosures@takeda.com

Condition Browse Module

ID	Term
D009477	Hereditary Sensory and Autonomic Neuropathies
D009369	Neoplasms

ID	Term
D009421	Nervous System Malformations
D009422	Nervous System Diseases
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases

ID	Term
C000627413	serabelisib

Title

Denominators

Categories

Title

Measurements

BG00064.7± 9.79
BG00159.0± 10.88
BG00259.3± 9.05
BG00345.3± 7.27
BG00456.3± 17.67
BG00552.7± 14.01
BG00654.3± 12.58
BG00765.0± 13.11
BG00856.4± 13.28
BG00953.3± 19.40
BG01064.7± 18.58
BG01150.0± 11.53
BG01255.0± 9.54
BG01357.4± 10.88
BG01465.7± 12.86
BG01562.7± 16.17
BG01661.0± 11.89
BG01752.7± 19.76
BG01853.7± 1.53
BG01966.7± 2.52
BG02061.3± 13.68
BG02172.5± 4.65
BG02260.3± 11.81
BG02366.0± 8.71
BG02459.5± 10.39
BG02559.4± 11.89

Gender

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0014 BG0025 BG0033 BG0042 BG0052 BG0062 BG0073 BG0089 BG0093 BG0101 BG0111 BG0123 BG0137 BG0141 BG0151 BG0165 BG0171 BG0182 BG0192 BG0204 BG0214 BG0224 BG0235 BG0246 BG02584
Male	BG0002 BG0012 BG0023 BG0031 BG004

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG0020 BG0030 BG0040 BG0050 BG0060 BG0070 BG0080 BG0090 BG0100 BG0110 BG0120 BG0130 BG0140 BG0150 BG0160 BG0170 BG0180 BG0190 BG0200 BG0210 BG0220 BG0231 BG0241 BG0252
Not Hispanic or Latino	BG0005 BG0016 BG0026 BG0034 BG004
Unknown or Not Reported	BG0001 BG0010 BG0022 BG0030 BG004

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG0006 BG0016 BG0028 BG0033 BG0043 BG0052 BG0061 BG0073 BG00812 BG0093 BG0103 BG0111 BG0123 BG01311 BG0142 BG0152 BG0167 BG0173 BG0183 BG0193 BG0206 BG0213 BG0223 BG02310 BG0248 BG025115

Black or African American

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Asian

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Other

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Not Reported

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Female Child Bearing Potential

Number

participants

Title

Denominators

Categories

Females of Child-bearing Potential

Title	Measurements
	BG0000 BG0010 BG0021 BG0031 BG0041 BG0050 BG0060 BG0070 BG0081 BG0090 BG0100 BG0111 BG0120 BG0130 BG0140 BG0150 BG0160 BG0170 BG0180 BG0190 BG0200 BG0210 BG0221 BG0231 BG0240 BG0257

Post-menopausal

Title	Measurements
	BG0004 BG0013 BG0023 BG003

Sterilized Females

Title	Measurements
	BG0000 BG0011 BG0021 BG003

Males (Excluded from this analysis)

Title	Measurements
	BG0002 BG0012 BG0023 BG003

Height

Height data was available only for 119 participants as follow: n=5,6,8,2,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,9,7.

Mean

Standard Deviation

centimeter (cm)

Title

Denominators

Categories

Title

Measurements

BG000161.70± 10.758
BG001164.29± 7.241
BG002165.25± 9.403
BG003164.15± 5.837
BG004164.19± 5.195
BG005161.81± 5.222
BG006165.17± 7.848
BG007163.49± 6.883
BG008163.08± 12.871
BG009158.76± 9.161
BG010168.76± 2.043
BG011173.43± 6.072
BG012164.67± 3.055
BG013167.46± 10.274
BG014170.22± 1.683
BG015168.93± 16.176
BG016168.32± 4.243
BG017169.83± 13.829
BG018169.52± 8.713
BG019168.11± 6.887
BG020165.97± 6.472
BG021159.00± 3.939
BG022157.05± 3.316
BG023168.79± 13.186
BG024164.87± 9.638
BG025165.49± 9.098

Weight

Weight data was available only for 123 participants as follow: n=5,6,8,4,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,10,8.

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title

Measurements

BG00062.18± 6.403
BG00171.15± 21.862
BG00273.48± 9.159
BG00367.65± 24.513
BG00472.48± 17.665
BG00561.54± 2.487
BG00657.73± 0.462
BG00763.41± 3.880
BG00869.14± 15.486
BG00965.03± 15.137
BG01070.76± 16.458
BG01183.39± 28.852
BG01260.60± 9.016
BG01373.78± 12.955
BG01472.26± 11.235
BG01575.22± 12.679
BG01679.84± 16.648
BG01781.07± 25.417
BG01882.72± 17.982
BG01962.61± 15.706
BG02064.59± 16.477
BG02173.65± 16.747
BG02265.37± 11.853
BG02370.51± 15.263
BG02465.11± 9.599
BG02570.17± 14.958

Body Surface Area (BSA)

BSA data was available only for 119 participants as follow: n=5,6,8,2,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,9,7.

Mean

Standard Deviation

square meter (m^2)

Title

Denominators

Categories

Title

Measurements

BG0001.67± 0.108
BG0011.78± 0.266
BG0021.83± 0.152
BG0031.85± 0.500
BG0041.81± 0.241
BG0051.66± 0.060
BG0061.63± 0.041
BG0071.70± 0.063
BG0081.76± 0.248
BG0091.69± 0.192
BG0101.81± 0.209
BG0111.99± 0.354
BG0121.66± 0.110
BG0131.85± 0.214
BG0141.85± 0.151
BG0151.88± 0.235
BG0161.92± 0.210
BG0171.95± 0.384
BG0181.97± 0.262
BG0191.70± 0.250
BG0201.72± 0.253
BG0211.80± 0.217
BG0221.68± 0.154
BG0231.82± 0.256
BG0241.71± 0.170
BG0251.79± 0.219

Title

Denominators

Categories

Title	Measurements
	OG000150 OG001900 OG002900 OG003NAThe MTD was not determined because PK data for FM showed limited increase in exposure above 900 mg. OG004NAThe MTD was not determined because PK data for FM showed limited increase in exposure above 900 mg. OG005500

Primary

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

participants

Baseline up to Cycle 27 Day 45

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

TEAE

Title	Measurements
	OG0006 OG0016 OG0028 OG003

Primary

Number of Participants With Highest Level of TEAEs Severity

Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

participants

Baseline up to Cycle 27 Day 45

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

Grade 1

Title	Measurements
	OG0001 OG0010 OG0020 OG003

Primary

Number of Participants With Clinically Meaningful Changes in Laboratory Values

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

participants

Baseline up to Cycle 27 Day 45

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Clinically Meaningful Changes in Vital Signs

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

participants

Baseline up to Cycle 27 day 45

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Primary

Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)

The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Number

participants

Baseline up to Cycle 27 Day 45

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

Overall Response Rate (ORR)

The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).

The full analysis set (FAS) population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0004 OG0016 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0.00 to 60.24) OG0010(0.00 to 45.93) OG00213(0.32 to 52.65) OG003

Secondary

Duration of Objective Response

Duration of response was to be calculated for participants who achieved CR or PR. Duration of objective response was defined as the number of days from the start date of PR or CR (whichever response was achieved first) to the first date that PD or disease progression was objectively documented. The duration of objective response was to be right-censored for participants who achieved CR or PR and met 1 of the following conditions: Non-protocol anticancer treatment started before documentation of PD; Documented PD after more than 1 missed disease assessment visit; Alive and did not have documentation of PD before a data analysis cutoff date.

The duration of objective response analysis was not performed due to change in planned analysis.

Posted

Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Clinical Benefit Rate (CBR)

Clinical benefit rate was defined as the participants who achieved stable disease (SD) for at least 15 weeks, CR, or PR. The estimate of the CBR was calculated as crude percentage of participants whose best ORR was CR, PR or SD for at least 90 days.

The FAS population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

percentage of participants

Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0004 OG0016 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG00025(0.63 to 80.59) OG00117(0.42 to 64.12) OG00238(8.52 to 75.51) OG003

Secondary

Cmax: Maximum Observed Plasma Concentration for TAK-117

Pharmacokinetic (PK) population included all participants who took at least 1 dose of study drug and had sufficient plasma concentration-time data to calculate PK parameters.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001747.61± 48.7(0.63 to 80.59) OG0011613.23± 58.5(0.42 to 64.12) OG0022736.60± 36.4(8.52 to 75.51)

Secondary

Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117

PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG000187.29± 102.1(0.63 to 80.59) OG001177.70± 124.0(0.42 to 64.12) OG002630.82± 70.0(8.52 to 75.51)

Secondary

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.

Posted

Median

Full Range

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001.5(1 to 4) OG0011.5(1 to 2) OG0022.0(1 to 4) OG003

Secondary

T 1/2z: Terminal Disposition Phase Half-life for TAK-117

PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.

Posted

Mean

Standard Deviation

hrs

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG0008.74± 3.0(0.63 to 80.59) OG0017.32± 3.3(0.42 to 64.12) OG00211.17± 4.5(8.52 to 75.51)

Secondary

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117

PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram hours per milliliter (ng*hr/mL)

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG00214 OG003

Title

Denominators

Categories

Title	Measurements
	OG00018008± 78.8(0.63 to 80.59) OG00113807± 93.2(0.42 to 64.12) OG00244733± 58.0(8.52 to 75.51)

Secondary

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117

No data is reported since serum concentration of TAK-117 were below the limit of quantification.

Posted

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 mg	Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG001	Process A: TAK-117 150 mg	Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG002	Process A: TAK-117 200 mg	Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG003	Process A: TAK-117 300 mg	Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG004	Process A: TAK-117 400 mg	Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG005	Process A: TAK-117 600 mg	Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG006	Process A: TAK-117 900 mg	Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG007	Process A: TAK-117 1200 mg	Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
OG008	Process B: TAK-117 300 mg	Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG009	Process B: TAK-117 400 mg	Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG010	Process B: TAK-117 500 mg	Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG011	Process B: TAK-117 600 mg	Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG012	Process B: TAK-117 900 mg	Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG013	Process B: TAK-117 1200 mg	Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
OG014	Process B: TAK-117 1500 mg	Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated

No data is reported since serum concentration of TAK-117 were below the limit of quantification.

Posted

Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Percent Change From Baseline in Pharmacodynamic Markers

Pharmacodynamic markers included phosphorylated ribosomal protein S6 (PS6), phosphorylated eukaryotic initiation factor 4E-binding protein 1 (P4EBP1), phosphorylated N-myc downstream regulated gene 1 (PNDRG1), phosphorylated proline-rich AKT substrate of 40 kilodaltons (PPRAS40), and phosphorylated serine/threonine protein kinase AKT (PAKT). Analysis population (n) for each skin biopsy biomarker is as follow: P4EBP1 (n=6,6,6,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PAKT and PNDRG1 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 6,0,6,2,2,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PS6 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0)."n" for each tumor tissue biomarkers is as follow: P4EBP1, PAKT, PNDRG1, and PS6 (n=1,1,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0).

Asat population where baseline and post-baseline assessments were available. The ASat population included all enrolled participants who received at least 1 dose of TAK-117.

Posted

Mean

Standard Deviation

percent change

Cycle 1 Day 8

ID	Title	Description
OG000	Process A: TAK-117 100 Milligram (mg), Once Daily (QD)	TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: TAK-117 150 mg, QD	TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: TAK-117 200 mg, QD	TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process A: TAK-117 300 mg, QD	TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG004	Process A: TAK-117 200 mg, MWF QW	TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG005	Process A: TAK-117 300 mg, MWF QW	TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG006	Process A: TAK-117 400 mg, MWF QW	TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG007	Process A: TAK-117 600 mg, MWF QW	TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG008	Process A: TAK-117 900 mg, MWF QW	TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG009	Process A: TAK-117 1200 mg, MWF QW	TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG010	Process A: TAK-117 200 mg, MTW QW	TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG011	Process A: TAK-117 400 mg, MTW QW	TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG012	Process A: TAK-117 600 mg, MTW QW	TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG013	Process A: TAK-117 900 mg, MTW QW	TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
OG014	Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW	TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG015	Process B: TAK-117 900 mg FM MWF QW	TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG016	Process B: TAK-117 1200 mg FM MWF QW	TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG017	Process B: TAK-117 600 mg FM MTW QW	TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG018	Process B: TAK-117 900 mg FM MTW QW	TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG019	Process B: TAK-117 1200 mg FM MTW QW	TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG020	Process B: TAK-117 1500 mg FM MTW QW	TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG021	Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW	TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG022	Process B: TAK-117 400 mg FM BID MWF QW	TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG023	Process B: TAK-117 500 mg FM BID MWF QW	TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG024	Process B: TAK-117 600 mg FM BID MWF QW	TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Units	Counts
Participants	OG0006 OG0016 OG0028 OG003

Title

Denominators

Categories

Skin Biopsy: P4EBP1

Title	Measurements
	OG000-27.94± 56.666 OG001-13.07± 39.758 OG002-61.41± 40.015 OG003

AEs leading to discontinuation of study drug

Title	Measurements
	OG0001 OG0012 OG0020 OG0031 OG0040 OG0050 OG0060 OG0070 OG0081 OG0091 OG0100 OG0111 OG0120 OG0132 OG0140 OG0151 OG0160 OG0170 OG0181 OG0191 OG0200 OG0211 OG0220 OG0231 OG0244

Skin Biopsy: PAKT

Title

Measurements

OG000-11.59± 33.833
OG001190.32± 257.212
OG002-30.02± 37.444
OG003-12.97± 5.896
OG004-18.75± 26.517
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009733.33± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NANone of the participants were evaluable for this category.
OG018NA± NANone of the participants were evaluable for this category.
OG019NA± NANone of the participants were evaluable for this category.
OG020NA± NANone of the participants were evaluable for this category.
OG021NA± NANone of the participants were evaluable for this category.
OG022NA± NANone of the participants were evaluable for this category.
OG023NA± NANone of the participants were evaluable for this category.
OG024NA± NANone of the participants were evaluable for this category.

Skin Biopsy: PNDRG1

Title

Measurements

OG000-9.82± 15.138
OG001-0.11± 35.915
OG002-10.11± 26.814
OG003-21.67± 35.355
OG00410.69± 31.283
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009-34.44± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NANone of the participants were evaluable for this category.
OG021NA± NANone of the participants were evaluable for this category.
OG022NA± NANone of the participants were evaluable for this category.
OG023NA± NANone of the participants were evaluable for this category.
OG024NA± NANone of the participants were evaluable for this category.

Skin Biopsy: PPRAS40

Title

Measurements

OG00069.56± 272.327
OG001NA± NANone of the participants were evaluable for this category.
OG002-26.90± 37.191
OG003-18.75± 61.872
OG004-14.17± 8.250
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NANone of the participants were evaluable for this category.
OG021NA± NANone of the participants were evaluable for this category.
OG022NA± NANone of the participants were evaluable for this category.
OG023NA± NANone of the participants were evaluable for this category.
OG024NA± NANone of the participants were evaluable for this category.

Skin Biopsy: PS6

Title

Measurements

OG000-15.23± 18.886
OG001-25.05± 15.883
OG002-11.88± 37.773
OG00322.70± 24.462
OG0049.54± 19.146
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG00946.15± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Tumor Tissue: P4EBP1

Title

Measurements

OG000236.00± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG001-97.56± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG002NA± NAData was not calculated since no participant was available for analysis.
OG003NA± NAData was not calculated since no participant was available for analysis.
OG0047.48± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Tumor Tissue: PAKT

Title

Measurements

OG000850.00± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG001-20.87± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG002NA± NAData was not calculated since no participant was available for analysis.
OG003NA± NAData was not calculated since no participant was available for analysis.
OG004-44.83± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Tumor Tissue: PNDRG1

Title

Measurements

OG000134.69± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG001-16.49± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG002NA± NAData was not calculated since no participant was available for analysis.
OG003NA± NAData was not calculated since no participant was available for analysis.
OG004134.29± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Tumor Tissue: PPRAS40

Title

Measurements

OG000196.83± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG001NA± NAData was not calculated since no participant was available for analysis.
OG002NA± NAData was not calculated since no participant was available for analysis.
OG003NA± NAData was not calculated since no participant was available for analysis.
OG00410.43± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Tumor Tissue: PS6

Title

Measurements

OG000200.00± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG0010.00± NAData was not calculated since no participant was available for analysis.
OG002NA± NAData was not calculated since no participant was available for analysis.
OG003NA± NAData was not calculated since no participant was available for analysis.
OG004-82.86± NAStandard deviation could not be calculated since only 1 participant was available for analysis.
OG005NA± NAData was not calculated since no participant was available for analysis.
OG006NA± NAData was not calculated since no participant was available for analysis.
OG007NA± NAData was not calculated since no participant was available for analysis.
OG008NA± NAData was not calculated since no participant was available for analysis.
OG009NA± NAData was not calculated since no participant was available for analysis.
OG010NA± NAData was not calculated since no participant was available for analysis.
OG011NA± NAData was not calculated since no participant was available for analysis.
OG012NA± NAData was not calculated since no participant was available for analysis.
OG013NA± NAData was not calculated since no participant was available for analysis.
OG014NA± NAData was not calculated since no participant was available for analysis.
OG015NA± NAData was not calculated since no participant was available for analysis.
OG016NA± NAData was not calculated since no participant was available for analysis.
OG017NA± NAData was not calculated since no participant was available for analysis.
OG018NA± NAData was not calculated since no participant was available for analysis.
OG019NA± NAData was not calculated since no participant was available for analysis.
OG020NA± NAData was not calculated since no participant was available for analysis.
OG021NA± NAData was not calculated since no participant was available for analysis.
OG022NA± NAData was not calculated since no participant was available for analysis.
OG023NA± NAData was not calculated since no participant was available for analysis.
OG024NA± NAData was not calculated since no participant was available for analysis.

Facility	Status	City	State	ZIP	Country	Contacts
		Boston	Massachusetts		United States

OG000	Process A: Total QD TAK-117 100-300 mg	TAK-117 100-300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG001	Process A: Total MWF QW 200-1200 mg	TAK-117 200-1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG002	Process A: Total MTW QW 200-900 mg	TAK-117 200-900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
OG003	Process B: Total FM MWF QW TAK-117 600-1200 mg	TAK-117 600-1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG004	Process B: Total FM MTW QW 600-1500 mg	TAK-117 600-1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
OG005	Process B: Total FM BID MWF QW 300-600 mg	TAK-117 300-600 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.