A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

Sponsor

Millennium Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03261947

Collaborator

(none)

101

Enrollment

Locations

Arms

Actual Duration (Months)

10.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of TAK-931 in participants with metastatic pancreatic cancer, colorectal cancer (CRC), squamous esophageal cancer (sqEC), and squamous non-small-cell lung cancer (sqNSCLC).

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Cancer Colorectal Cancer Esophageal Neoplasms Carcinoma, Non-small-cell Lung	Drug: TAK-931	Phase 2

Detailed Description

Pancreatic Arm Now Closed.

The drug being tested in this study is called TAK-931. TAK-931 blocks function of a specific protein called CDC7 kinase in the human body. TAK-931 is being tested in participants with metastatic cancer (colorectal, pancreatic, sqNSCLC and sqEC) in the United States and Japan and also in the participants with any type of metastatic cancer with no standard therapeutic alternative in the United States only. This study will look at the safety, tolerability and pharmacokinetics of TAK-931.

The study will enroll approximately 160 participants. Participants will be enrolled in 5 cohorts: 1) Western safety cohort, to be enrolled in the United States only, will include non-Japanese participants with metastatic solid tumors and no standard therapeutic alternative, 2) Metastatic pancreatic cancer cohort, 3) Metastatic colorectal cancer cohort, 4) Metastatic sqNSCLC cohort, and 5) Metastatic sqEC cohort. All participants will receive:

• TAK-931 50 mg (2x25 mg or 5x10 mg) capsules

All participants will be asked to take one 50 mg (2x25 mg or 5x10 mg) capsule at the same time of the day every day for 14 days, followed by 7 days break in 21-day cycles throughout the study.

This multi-center trial will be conducted in the United States and Japan. The overall time to participate in this study is approximately 24 months. Participants will make multiple visits to the clinic. Participants in both Western cohort and disease specific cohorts will be followed for progression-free survival every 12 weeks after the last dose of the study drug until the occurrence of disease progression, loss to follow up, consent withdrawal, death, start of subsequent antineoplastic therapy, study termination, or until 6 months after discontinuation of the study treatment, whichever occurs first. Once disease progression is confirmed, participants in the disease-specific cohorts will be followed for overall survival every 12 weeks until death, loss to follow up, consent withdrawal, study termination, or transfer of a participant to a long term safety study, single participant investigational new drug application, or similar program after the last dose of the study drug.

Study Design

Study Type:

Interventional

Actual Enrollment :

101 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Phase 2, Parallel Arm Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 Single Agent in Patients With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

Actual Study Start Date :

Oct 25, 2017

Actual Primary Completion Date :

Aug 24, 2020

Actual Study Completion Date :

Aug 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Western Safety Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	Drug: TAK-931 TAK-931 hard gelatin capsules
Experimental: Pancreatic Cancer Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	Drug: TAK-931 TAK-931 hard gelatin capsules
Experimental: Metastatic CRC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	Drug: TAK-931 TAK-931 hard gelatin capsules
Experimental: sqEC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	Drug: TAK-931 TAK-931 hard gelatin capsules
Experimental: sqNSCLC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.	Drug: TAK-931 TAK-931 hard gelatin capsules

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort [Cycle 1 (each cycle = 21 days)]
DLT:Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events(CTCAE) version4.03;Non-febrile Grade 4 neutropenia; febrile neutropenia: Grade >=3 neutropenia; Grade4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in initiation of Cycle 2 by >14 days due to lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by echocardiogram(ECHO) or multiple gated acquisition(MUGA) scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of planned TAK-931 dosing in Cycle 1 due to study drug-related adverse events(AEs); Grade >=3 nonhematologic toxicity with few exceptions: Grade 3 arthralgia/myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort [From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)]
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
Disease Control Rate (DCR) in Tumor-Specific Cohorts [From first dose up to end of treatment (Up to approximately 14 months)]
DCR was defined as percentage of participants documented to have unconfirmed CR, PR, or SD for at least 6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as the best response. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Secondary Outcome Measures

Cmax: Maximum Observed Plasma Concentration for TAK-931 [Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931 [Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931 [Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 [Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
CLr: Renal Clearance of TAK-931 [Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose]
CLr is a measure of apparent clearance of the drug from the plasma, renal clearance is a measure of drug excreted through kidneys/urine per unit time.
t1/2z: Terminal Disposition Phase Half-life for TAK-931 [Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
CLss/F: Steady-state Apparent Oral Clearance for TAK-931 [Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
CL/F was defined as apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC.
Rac(AUC): Accumulation Ratio Based on AUC Over the Dosing Interval (AUCτ) for TAK-931 [Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose]
Overall Response Rate (CR and PR) [From first dose up to end of treatment (Up to approximately 14 months)]
Overall response rate was defined as percentage of participants documented to have unconfirmed CR or PR according to RECIST v1.1 as the best response. CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD.
Duration of Response (DOR) [From first documented response until disease progression or end of treatment, whichever occurs first (Up to 14 months)]
DOR was defined as the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression. Per RECIST V1.1, CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Progression Free Survival (PFS) [From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)]
PFS was defined as the time from the date of first dose to the date of first documentation of PD (including clinical progression or clinical deterioration) or death due to any cause, whichever occurs first. Per RECIST V1.1, PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Overall Survival (OS) in the Tumor-Specific Cohorts [Up to approximately 43 months]
OS was defined as the time from the date of first dose of study drug to death due to any cause.
Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts [From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)]
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4:Life-threatening consequences, urgent intervention indicated; Grade 5:Death related to AE. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts [From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)]
Clinical laboratory tests included hematology, clinical chemistry and urinalysis. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements, Reported as Adverse Events in Tumor-Specific Cohorts [From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)]
Vital signs included assessments of systolic and diastolic blood pressure (BP), heart rate (HR), and body temperature. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult male or female participants aged >=20 years (Japan) or >=18 years (United States).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has pathologically confirmed metastatic pancreatic adenocarcinoma that has progressed after, at least, a first line of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed metastatic adenocarcinoma of the colon or rectum who have progressed to at least 2 lines of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed locally advanced or metastatic sqEC that has progressed after at least a first line of standard systemic therapy for metastatic disease. First-line participants can be enrolled if a platinum doublet is contraindicated or refused by the participants, OR pathologically confirmed locally advanced or metastatic sqNSCLC that has progressed after at least 2 lines of standard systemic therapy for metastatic disease.
For the Western safety cohort only: participants with locally advanced or metastatic solid tumor for whom no standard treatment with an established survival benefit is available or if the participant refuses other standard therapy.
For disease-specific cohort participants: measurable disease per RECIST v. 1.1
Left ventricular ejection fraction greater than (>) 50% as measured by ECHO or MUGA scan within 4 weeks before receiving the first dose of study drug.
Recovered to Grade 1 or baseline from all toxic effects of previous therapy (except alopecia or neuropathy).
Suitable venous access for the study-required blood sampling.
For the Western safety cohort only: willingness to undergo serial skin tissue biopsies.
For disease-specific cohort participants: Must have an archival (banked) tumor sample or agree to have a new (fresh) tumor biopsy during the screening period. If a new tumor sample is needed, the disease should be accessible for a nonsignificant risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures not extending beyond the stomach or bowel). For participants in the Western safety cohort, this biopsy is optional.

Exclusion Criteria:

Participants who require continuous use of proton pump inhibitors (PPIs) or histamine-2 (H2) receptor antagonists and participants who are taking PPIs within 5 days before the first dose of study drug.
Treatment with clinically significant enzyme inducers, such as phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, or Saint John's wort within 14 days before the first dose of study drug.
Treatment with any systemic anticancer treatment (including investigational products) within 30 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
History of any of the following within the last 3 months before administration of the first dose of study drug:

Ischemic myocardial event including angina requiring therapy and artery revascularization procedures, myocardial infarction, and unstable symptomatic ischemic heart disease.
Ischemic cerebrovascular event, including transient ischemic attack and artery, revascularization procedures.
Significant, uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia).
New York Heart Association Class III to IV heart failure.
Any other cardiac condition that, in the opinion of the investigator, could pose an additional risk for participation in the study (example, pericardial effusion or restrictive cardiomyopathy).
Baseline prolongation of the QT interval corrected for heart rate (HR) using Fridericia's formula [QT interval corrected for heart rate using Fridericia's formula (QTcF); example, repeated demonstration of QTcF interval >480 millisecond (ms), history of congenital long QT syndrome, or torsades de pointes].

Hypertension that is unstable or not controlled by medication.
History of uncontrolled brain metastasis unless:

Previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery, and
Stable disease (SD) for >=30 days, without steroid use (or stable steroid dose established for >=14 days before the first dose of TAK-931).

Known history of human immunodeficiency virus infection.
Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C virus (HCV) infection viral load. Note: Participants who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable HBV viral load.
Prior treatment with radiation therapy involving >=25% of the hematopoietically active bone marrow within 3 months before the first dose of study drug.
Participants with known microsatellite instability-high (MSI-H) genotype or known wild type tumor protein 53 (TP53) per local testing.
Western Safety Cohort Only: Participants with Japanese heredity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarah Cannon Research Institute Oncology Research Consortium	Denver	Colorado	United States	80218
2	Sarah Cannon Research Institute	Sarasota	Florida	United States	34232
3	Allina Health Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55404
4	Siteman Cancer Center	Saint Louis	Missouri	United States	63110
5	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89119
6	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
7	SCRI - Tennessee Oncology - Nashville - Southern Hills Clinic	Nashville	Tennessee	United States	37203
8	Virginia Mason Medical Center	Seattle	Washington	United States	98101-2756
9	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
10	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director: Study Director, Takeda

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT03261947

Other Study ID Numbers:

TAK-931-2001
U1111-1192-7975
JapicCTI-163200

First Posted:

Aug 25, 2017

Last Update Posted:

Sep 20, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Millennium Pharmaceuticals, Inc.

Drug therapy

Additional relevant MeSH terms:

Colorectal Neoplasms

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Esophageal Neoplasms

Study Results

Participant Flow

Recruitment Details

Participants took part in the study at 12 investigative sites in Japan and the United States from 25 October 2017 to 24 August 2020.

Pre-assignment Detail

The study had two parts, Part 1 (Safety Cohort) enrolled western participants with locally advanced/metastatic solid tumors to receive TAK-931 and assessed safety, tolerability and pharmacokinetics. In Part 2, participants were enrolled into Tumor (Disease)-Specific Cohorts based on tumor criteria: pancreatic cancer, metastatic colorectal cancer (CRC), squamous esophageal cancer (sqEC), squamous non-small-cell lung cancer (sqNSCLC) to receive TAK-931 and were assessed for antitumor activity.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Period Title: Overall Study
STARTED	12	15	35	21	18
COMPLETED	0	2	5	0	1
NOT COMPLETED	12	13	30	21	17

Baseline Characteristics

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort	Total
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.	Total of all reporting groups
Overall Participants	12	15	35	21	18	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (7.16)	63.1 (12.27)	58.3 (11.93)	64.2 (7.71)	64.4 (7.74)	61.5 (10.23)
Sex: Female, Male (Count of Participants)
Female	5 41.7%	5 33.3%	19 54.3%	4 19%	7 38.9%	40 39.6%
Male	7 58.3%	10 66.7%	16 45.7%	17 81%	11 61.1%	61 60.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 6.7%	1 2.9%	0 0%	0 0%	2 2%
Not Hispanic or Latino	11 91.7%	12 80%	34 97.1%	21 100%	18 100%	96 95%
Unknown or Not Reported	1 8.3%	2 13.3%	0 0%	0 0%	0 0%	3 3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	3 20%	8 22.9%	16 76.2%	2 11.1%	29 28.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 25%	0 0%	3 8.6%	1 4.8%	1 5.6%	8 7.9%
White	9 75%	12 80%	24 68.6%	4 19%	15 83.3%	64 63.4%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Japan	0 0%	3 20%	8 22.9%	16 76.2%	2 11.1%	29 28.7%
United States	12 100%	12 80%	27 77.1%	5 23.8%	16 88.9%	72 71.3%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	172.47 (13.371)	170.61 (11.596)	168.64 (10.203)	167.11 (7.975)	172.26 (10.693)	169.75 (10.513)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	79.33 (16.052)	73.22 (22.763)	79.90 (17.457)	57.07 (10.358)	77.70 (18.770)	73.87 (19.076)
Substance Use (Count of Participants)
Tobacco	0 0%	0 0%	0 0%	12 57.1%	3 16.7%	15 14.9%
Cigarette	0 0%	0 0%	0 0%	6 28.6%	15 83.3%	21 20.8%
Cigar	0 0%	0 0%	0 0%	1 4.8%	0 0%	1 1%
Pipe	0 0%	0 0%	0 0%	1 4.8%	0 0%	1 1%
Smoking Classification (Count of Participants)
Never Smoked	12 100%	15 100%	35 100%	2 9.5%	1 5.6%	65 64.4%
Current Smoker	0 0%	0 0%	0 0%	3 14.3%	7 38.9%	10 9.9%
Former Smoker	0 0%	0 0%	0 0%	16 76.2%	10 55.6%	26 25.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort
Description	DLT:Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events(CTCAE) version4.03;Non-febrile Grade 4 neutropenia; febrile neutropenia: Grade >=3 neutropenia; Grade4 thrombocytopenia; Grade >=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in initiation of Cycle 2 by >14 days due to lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by echocardiogram(ECHO) or multiple gated acquisition(MUGA) scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by investigator to be related to study drug and dose-limiting; Participants receiving <50% of doses (<7 doses) of planned TAK-931 dosing in Cycle 1 due to study drug-related adverse events(AEs); Grade >=3 nonhematologic toxicity with few exceptions: Grade 3 arthralgia/myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea.
Time Frame	Cycle 1 (each cycle = 21 days)

Outcome Measure Data

Analysis Population Description
DLT-evaluable Analysis Set included all participants in the Western Safety Cohort who received at least 1 of their planned TAK-931 doses during their first cycle of treatment (unless interrupted by related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether a DLT occurred. As pre-specified in the protocol, DLTs were collected only from participants in the Western Safety Cohort who were evaluable in DLT-evaluable Analysis Set.

Analysis Population Description

DLT-evaluable Analysis Set included all participants in the Western Safety Cohort who received at least 1 of their planned TAK-931 doses during their first cycle of treatment (unless interrupted by related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether a DLT occurred. As pre-specified in the protocol, DLTs were collected only from participants in the Western Safety Cohort who were evaluable in DLT-evaluable Analysis Set.

Arm/Group Title	Western Safety Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
Measure Participants	2
Number [percentage of participants]	50 416.7%

2. Primary Outcome

Title	Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort
Description	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
Time Frame	From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure reports data only in the participants with locally advanced or metastatic solid tumors in the Western Safety Cohort.

Arm/Group Title	Western Safety Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
Measure Participants	12
TEAEs	100 833.3%
SAEs	58.3 485.8%
TEAEs Leading to Dose Modifications	33.3 277.5%
TEAEs Leading to Treatment Discontinuation	8.3 69.2%

3. Primary Outcome

Title	Disease Control Rate (DCR) in Tumor-Specific Cohorts
Description	DCR was defined as percentage of participants documented to have unconfirmed CR, PR, or SD for at least 6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as the best response. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	From first dose up to end of treatment (Up to approximately 14 months)

Outcome Measure Data

Analysis Population Description
Response-evaluable Analysis Set included all participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline response assessment. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Arm/Group Title	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	13	31	19	17
Number [percentage of participants]	46.2 385%	51.6 344%	52.6 150.3%	58.8 280%

4. Secondary Outcome

Title	Cmax: Maximum Observed Plasma Concentration for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
Pharmacokinetic (PK) Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Analysis Population Description

Pharmacokinetic (PK) Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	12	15	34
Cycle 1 Day 1	173.61 (59.677)	204.69 (90.527)	185.46 (61.158)
Cycle 1 Day 8	196.17 (73.702)	180.55 (75.036)	216.18 (121.488)

5. Secondary Outcome

Title	Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Analysis Population Description

PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	12	15	34
Cycle 1 Day 1	1.57	2.00	1.85
Cycle 1 Day 8	1.59	2.00	1.97

6. Secondary Outcome

Title	AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Analysis Population Description

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	12	15	34
Cycle 1 Day 1	1190.22 (540.877)	1166.40 (362.856)	1302.40 (391.035)
Cycle 1 Day 8	1475.88 (749.707)	1290.72 (615.542)	1542.82 (507.733)

7. Secondary Outcome

Title	AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Analysis Population Description

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	12	15	34
Cycle 1 Day 1	1165.52 (552.287)	1114.23 (388.844)	1311.41 (388.557)
Cycle 1 Day 8	1426.70 (774.257)	1289.33 (616.737)	1551.57 (497.856)

8. Secondary Outcome

Title	CLr: Renal Clearance of TAK-931
Description	CLr is a measure of apparent clearance of the drug from the plasma, renal clearance is a measure of drug excreted through kidneys/urine per unit time.
Time Frame	Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for urine PK sampling was collected only for participants in Western Safety Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Arm/Group Title	Western Safety Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
Measure Participants	4
Mean (Standard Deviation) [L/h]	2.16 (1.913)

9. Secondary Outcome

Title	t1/2z: Terminal Disposition Phase Half-life for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Analysis Population Description

PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	11	10	11
Median (Full Range) [hour]	5.95	5.53	6.18

10. Secondary Outcome

Title	CLss/F: Steady-state Apparent Oral Clearance for TAK-931
Description	CL/F was defined as apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC.
Time Frame	Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Analysis Population Description

PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	11	10	11
Mean (Standard Deviation) [L/h]	39.71 (14.135)	45.58 (18.877)	35.57 (10.778)

11. Secondary Outcome

Title	Rac(AUC): Accumulation Ratio Based on AUC Over the Dosing Interval (AUCτ) for TAK-931
Description
Time Frame	Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

Analysis Population Description
PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Analysis Population Description

PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
Measure Participants	11	10	11
Mean (Standard Deviation) [ratio]	1.27 (0.317)	1.10 (0.299)	1.12 (0.203)

12. Secondary Outcome

Title	Overall Response Rate (CR and PR)
Description	Overall response rate was defined as percentage of participants documented to have unconfirmed CR or PR according to RECIST v1.1 as the best response. CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD.
Time Frame	From first dose up to end of treatment (Up to approximately 14 months)

Outcome Measure Data

Analysis Population Description
Response-evaluable Analysis Set included all participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline response assessment.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	12	13	31	19	17
Number [percentage of participants]	8.3 69.2%	0 0%	0 0%	5.3 25.2%	0 0%

13. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR was defined as the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression. Per RECIST V1.1, CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	From first documented response until disease progression or end of treatment, whichever occurs first (Up to 14 months)

Outcome Measure Data

Analysis Population Description
Response-evaluable Analysis Set included all participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline response assessment. Only responders were to be analyzed for this outcome measure.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	1	0	0	1	0
Median (95% Confidence Interval) [months]	NA	NA

14. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS was defined as the time from the date of first dose to the date of first documentation of PD (including clinical progression or clinical deterioration) or death due to any cause, whichever occurs first. Per RECIST V1.1, PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug.

Arm/Group Title	Western Safety Cohort	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	12	15	35	21	18
Median (95% Confidence Interval) [months]	2.05	1.31	1.45	3.02	2.12

15. Secondary Outcome

Title	Overall Survival (OS) in the Tumor-Specific Cohorts
Description	OS was defined as the time from the date of first dose of study drug to death due to any cause.
Time Frame	Up to approximately 43 months

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Arm/Group Title	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	15	35	21	18
Median (95% Confidence Interval) [months]	4.67	7.72	8.61	NA

16. Secondary Outcome

Title	Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts
Description	An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. TEAEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4:Life-threatening consequences, urgent intervention indicated; Grade 5:Death related to AE. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria.
Time Frame	From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Arm/Group Title	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	15	35	21	18
Grade >=3 TEAEs	73.3 610.8%	54.3 362%	57.1 163.1%	44.4 211.4%
SAEs	40.0 333.3%	22.9 152.7%	23.8 68%	16.7 79.5%
TEAEs Leading to Dose Modifications	53.3 444.2%	48.6 324%	52.4 149.7%	38.9 185.2%
TEAEs Leading to Treatment Discontinuation	13.3 110.8%	8.6 57.3%	9.5 27.1%	0 0%

17. Secondary Outcome

Title	Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts
Description	Clinical laboratory tests included hematology, clinical chemistry and urinalysis. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.
Time Frame	From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Arm/Group Title	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	15	35	21	18
Neutrophil Count Decreased	26.7 222.5%	17.1 114%	38.1 108.9%	27.8 132.4%
White Blood Cell Count Decreased	20.0 166.7%	8.6 57.3%	42.9 122.6%	5.6 26.7%
Lymphocyte Count Decreased	13.3 110.8%	0 0%	0 0%	5.6 26.7%
Aspartate Aminotransferase Increased	6.7 55.8%	2.9 19.3%	0 0%	5.6 26.7%
Alanine Aminotransferase Increased	6.7 55.8%	0 0%	0 0%	5.6 26.7%
Blood Bilirubin Increased	0 0%	2.9 19.3%	0 0%	0 0%
Hepatic Enzyme Increased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Creatinine Increased	20.0 166.7%	0 0%	4.8 13.7%	0 0%
Blood Creatinine Decreased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Urea Increased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Chloride Decreased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Sodium Decreased	0 0%	2.9 19.3%	0 0%	0 0%
Platelet Count Decreased	0 0%	5.7 38%	4.8 13.7%	0 0%
Blood Alkaline Phosphatase Increased	6.7 55.8%	5.7 38%	0 0%	0 0%
Blood Uric Acid Increased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Glucose Increased	6.7 55.8%	0 0%	0 0%	0 0%
Blood Albumin Decreased	6.7 55.8%	0 0%	0 0%	0 0%
Protein Total Decreased	6.7 55.8%	0 0%	0 0%	0 0%
Haematocrit Decreased	6.7 55.8%	0 0%	0 0%	0 0%
Red Blood Cell Count Decreased	6.7 55.8%	0 0%	0 0%	0 0%

18. Secondary Outcome

Title	Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements, Reported as Adverse Events in Tumor-Specific Cohorts
Description	Vital signs included assessments of systolic and diastolic blood pressure (BP), heart rate (HR), and body temperature. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.
Time Frame	From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Arm/Group Title	Pancreatic Cancer Cohort	Metastatic CRC Cohort	sqEC Cohort	sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
Measure Participants	15	35	21	18
Orthostatic Hypotension	0 0%	2.9 19.3%	0 0%	0 0%
Tachycardia	0 0%	5.7 38%	0 0%	0 0%
Bradycardia	0 0%	2.9 19.3%	0 0%	0 0%
Atrial Fibrillation	0 0%	2.9 19.3%	0 0%	0 0%
Increase in HR	0 0%	2.9 19.3%	0 0%	0 0%

Adverse Events

	Western Safety Cohort		Pancreatic Cancer Cohort		Metastatic CRC Cohort		sqEC Cohort		sqNSCLC Cohort
Time Frame	All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.

Arm/Group Title	Western Safety Cohort		Pancreatic Cancer Cohort		Metastatic CRC Cohort		sqEC Cohort		sqNSCLC Cohort
Arm/Group Description	TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.		TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.		TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.		TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.		TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/12 (83.3%)		13/15 (86.7%)		17/35 (48.6%)		12/21 (57.1%)		8/18 (44.4%)
Serious Adverse Events
	Western Safety Cohort		Pancreatic Cancer Cohort		Metastatic CRC Cohort		sqEC Cohort		sqNSCLC Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/12 (58.3%)		6/15 (40%)		8/35 (22.9%)		5/21 (23.8%)		3/18 (16.7%)
Blood and lymphatic system disorders
Febrile neutropenia	0/12 (0%)		0/15 (0%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Gastrointestinal disorders
Abdominal pain	1/12 (8.3%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Upper gastrointestinal haemorrhage	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Gastrointestinal haemorrhage	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Small intestinal obstruction	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Nausea	0/12 (0%)		2/15 (13.3%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Vomiting	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Duodenal ulcer perforation	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Constipation	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Intestinal obstruction	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Large intestine perforation	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
General disorders
Disease progression	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Hepatobiliary disorders
Bile duct stenosis	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Infections and infestations
Abdominal infection	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Pneumonia	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Sepsis	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Pyelonephritis	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Investigations
Neutrophil count decreased	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Metabolism and nutrition disorders
Dehydration	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		1/21 (4.8%)		0/18 (0%)
Hyponatraemia	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/12 (0%)		0/15 (0%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Pain in extremity	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Muscular weakness	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion	2/12 (16.7%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Cancer pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Tumour pain	0/12 (0%)		0/15 (0%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Colorectal cancer	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Oesophageal carcinoma	0/12 (0%)		0/15 (0%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Pancreatic carcinoma	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Pancreatic carcinoma metastatic	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Nervous system disorders
Migraine	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Dizziness	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Psychiatric disorders
Mental status changes	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Renal and urinary disorders
Acute kidney injury	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		1/21 (4.8%)		0/18 (0%)
Pneumonia aspiration	0/12 (0%)		0/15 (0%)		0/35 (0%)		1/21 (4.8%)		0/18 (0%)
Pneumonitis	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Pulmonary alveolar haemorrhage	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Pulmonary embolism	0/12 (0%)		0/15 (0%)		1/35 (2.9%)		0/21 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Western Safety Cohort		Pancreatic Cancer Cohort		Metastatic CRC Cohort		sqEC Cohort		sqNSCLC Cohort
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)		8/15 (53.3%)		27/35 (77.1%)		14/21 (66.7%)		14/18 (77.8%)
Blood and lymphatic system disorders
Anaemia	1/12 (8.3%)		2/15 (13.3%)		4/35 (11.4%)		2/21 (9.5%)		3/18 (16.7%)
Neutropenia	0/12 (0%)		0/15 (0%)		0/35 (0%)		2/21 (9.5%)		2/18 (11.1%)
Increased tendency to bruise	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Cardiac disorders
Tachycardia	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Ear and labyrinth disorders
Ear pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Eye disorders
Vision blurred	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Vitreous floaters	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Gastrointestinal disorders
Nausea	3/12 (25%)		5/15 (33.3%)		16/35 (45.7%)		7/21 (33.3%)		7/18 (38.9%)
Vomiting	1/12 (8.3%)		3/15 (20%)		14/35 (40%)		2/21 (9.5%)		7/18 (38.9%)
Constipation	2/12 (16.7%)		2/15 (13.3%)		6/35 (17.1%)		0/21 (0%)		4/18 (22.2%)
Abdominal pain	3/12 (25%)		1/15 (6.7%)		6/35 (17.1%)		0/21 (0%)		2/18 (11.1%)
Diarrhoea	0/12 (0%)		1/15 (6.7%)		5/35 (14.3%)		0/21 (0%)		2/18 (11.1%)
Dyspepsia	0/12 (0%)		0/15 (0%)		4/35 (11.4%)		0/21 (0%)		0/18 (0%)
Abdominal pain upper	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Gastrooesophageal reflux disease	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		2/18 (11.1%)
Proctalgia	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Abdominal distension	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Ascites	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Faeces discoloured	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Flatulence	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Gingival bleeding	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Rectal discharge	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Rectal haemorrhage	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Retching	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Stomatitis	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
General disorders
Fatigue	4/12 (33.3%)		5/15 (33.3%)		3/35 (8.6%)		2/21 (9.5%)		2/18 (11.1%)
Malaise	1/12 (8.3%)		0/15 (0%)		3/35 (8.6%)		2/21 (9.5%)		0/18 (0%)
Early satiety	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Oedema peripheral	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Asthenia	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Chest pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Chills	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Pain	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Pyrexia	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Infections and infestations
Upper respiratory tract infection	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		3/18 (16.7%)
Pneumonia	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		1/18 (5.6%)
Candida infection	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Cellulitis	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Kidney infection	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Localised infection	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Skin infection	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Injury, poisoning and procedural complications
Contusion	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Foot fracture	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Wound	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Investigations
Neutrophil count decreased	3/12 (25%)		2/15 (13.3%)		4/35 (11.4%)		6/21 (28.6%)		5/18 (27.8%)
White blood cell count decreased	0/12 (0%)		1/15 (6.7%)		3/35 (8.6%)		7/21 (33.3%)		1/18 (5.6%)
Ejection fraction decreased	2/12 (16.7%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		2/18 (11.1%)
Weight decreased	2/12 (16.7%)		1/15 (6.7%)		0/35 (0%)		2/21 (9.5%)		0/18 (0%)
Blood alkaline phosphatase increased	0/12 (0%)		1/15 (6.7%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Alanine aminotransferase increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Aspartate aminotransferase increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Lymphocyte count decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Platelet count decreased	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Blood albumin decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood chloride decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood creatinine decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood creatinine increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood glucose increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood urea increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Blood uric acid increased	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Haematocrit decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Hepatic enzyme increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Protein total decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Red blood cell count decreased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Weight increased	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Metabolism and nutrition disorders
Decreased appetite	4/12 (33.3%)		2/15 (13.3%)		6/35 (17.1%)		6/21 (28.6%)		5/18 (27.8%)
Dehydration	0/12 (0%)		0/15 (0%)		3/35 (8.6%)		0/21 (0%)		2/18 (11.1%)
Hyponatraemia	0/12 (0%)		1/15 (6.7%)		3/35 (8.6%)		0/21 (0%)		0/18 (0%)
Hypercalcaemia	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Hyperglycaemia	1/12 (8.3%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Hyperuricaemia	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Hypokalaemia	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Iron deficiency	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Musculoskeletal and connective tissue disorders
Back pain	0/12 (0%)		0/15 (0%)		4/35 (11.4%)		0/21 (0%)		1/18 (5.6%)
Myalgia	3/12 (25%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Arthralgia	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Musculoskeletal pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Pain in extremity	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Flank pain	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Muscle spasms	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Muscular weakness	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Musculoskeletal chest pain	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		2/21 (9.5%)		0/18 (0%)
Malignant pleural effusion	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Tumour pain	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Nervous system disorders
Dizziness	1/12 (8.3%)		2/15 (13.3%)		3/35 (8.6%)		0/21 (0%)		1/18 (5.6%)
Dysgeusia	1/12 (8.3%)		0/15 (0%)		3/35 (8.6%)		0/21 (0%)		2/18 (11.1%)
Headache	1/12 (8.3%)		0/15 (0%)		3/35 (8.6%)		0/21 (0%)		2/18 (11.1%)
Peripheral sensory neuropathy	1/12 (8.3%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		1/18 (5.6%)
Tremor	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Neuropathy peripheral	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Psychiatric disorders
Insomnia	1/12 (8.3%)		1/15 (6.7%)		2/35 (5.7%)		0/21 (0%)		1/18 (5.6%)
Depression	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Renal and urinary disorders
Dysuria	2/12 (16.7%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Reproductive system and breast disorders
Vulvovaginal pruritus	0/5 (0%)		1/5 (20%)		0/19 (0%)		0/4 (0%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/12 (16.7%)		1/15 (6.7%)		4/35 (11.4%)		0/21 (0%)		1/18 (5.6%)
Cough	1/12 (8.3%)		2/15 (13.3%)		0/35 (0%)		0/21 (0%)		4/18 (22.2%)
Haemoptysis	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Chronic obstructive pulmonary disease	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Epistaxis	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Pleuritic pain	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Productive cough	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Respiratory tract congestion	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Upper-airway cough syndrome	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/12 (8.3%)		1/15 (6.7%)		3/35 (8.6%)		3/21 (14.3%)		5/18 (27.8%)
Pruritus	2/12 (16.7%)		1/15 (6.7%)		4/35 (11.4%)		0/21 (0%)		1/18 (5.6%)
Rash	0/12 (0%)		2/15 (13.3%)		3/35 (8.6%)		0/21 (0%)		1/18 (5.6%)
Dry skin	1/12 (8.3%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		2/18 (11.1%)
Dermatitis acneiform	0/12 (0%)		0/15 (0%)		2/35 (5.7%)		0/21 (0%)		0/18 (0%)
Rash maculo-papular	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Dermatitis bullous	1/12 (8.3%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Night sweats	0/12 (0%)		1/15 (6.7%)		0/35 (0%)		0/21 (0%)		0/18 (0%)
Photosensitivity reaction	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Skin ulcer	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		1/18 (5.6%)
Vascular disorders
Hot flush	0/12 (0%)		0/15 (0%)		0/35 (0%)		0/21 (0%)		2/18 (11.1%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.

Results Point of Contact

Name/Title	Study Director
Organization	Takeda
Phone	+1-877-825-3327
Email	TrialDisclosures@takeda.com

Responsible Party:

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT03261947

Other Study ID Numbers:

TAK-931-2001
U1111-1192-7975
JapicCTI-163200

First Posted:

Aug 25, 2017

Last Update Posted:

Sep 20, 2021

Last Verified:

Aug 1, 2021

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors

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