A Study to Evaluate the Safety, Tolerability, and Activit... | NCT03261947 | Trialant
NCT03261947
Sponsor
Millennium Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Sep 20, 2021Actual
Enrollment
101Actual
Phase
Phase 2
Conditions
Metastatic Pancreatic Cancer
Colorectal Cancer
Esophageal Neoplasms
Carcinoma, Non-small-cell Lung
Interventions
TAK-931
Countries
United States
Japan
Protocol Section
Identification Module
NCT ID
NCT03261947
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TAK-931-2001
Secondary IDs
ID
Type
Description
Link
U1111-1192-7975
Registry Identifier
World Health Organization
JapicCTI-163200
Registry Identifier
JapicCTI
Brief Title
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
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
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 25, 2017Actual
Primary Completion Date
Aug 24, 2020Actual
Completion Date
Aug 24, 2020Actual
First Submitted Date
Aug 23, 2017
First Submission Date that Met QC Criteria
Aug 23, 2017
First Posted Date
Aug 25, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 24, 2021
Results First Submitted that Met QC Criteria
Aug 24, 2021
Results First Posted Date
Sep 20, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 24, 2021
Last Update Posted Date
Sep 20, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Millennium Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to 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).
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.
Conditions Module
Conditions
Metastatic Pancreatic Cancer
Colorectal Cancer
Esophageal Neoplasms
Carcinoma, Non-small-cell Lung
Keywords
Drug therapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Western Safety Cohort
Experimental
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
Pancreatic Cancer Cohort
Experimental
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
Metastatic CRC Cohort
Experimental
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
sqEC Cohort
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
TAK-931
Drug
TAK-931 hard gelatin capsules
Metastatic CRC Cohort
Pancreatic Cancer Cohort
Western Safety Cohort
sqEC Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort
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.
Cycle 1 (each cycle = 21 days)
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
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.
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
Disease Control Rate (DCR) in Tumor-Specific Cohorts
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 Outcomes
Measure
Description
Time Frame
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
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Study Director
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sarah Cannon Research Institute Oncology Research Consortium
Denver
Colorado
80218
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 16, 2018
Aug 24, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: TAK-931
sqNSCLC Cohort
Experimental
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
sqNSCLC Cohort
From first dose up to end of treatment (Up to approximately 14 months)
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
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.
Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose
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
CL/F was defined as apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC.
Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
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)
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.
From first dose up to end of treatment (Up to approximately 14 months)
Duration of Response (DOR)
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.
From first documented response until disease progression or end of treatment, whichever occurs first (Up to 14 months)
Progression Free Survival (PFS)
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.
From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)
Overall Survival (OS) in the Tumor-Specific Cohorts
OS was defined as the time from the date of first dose of study drug to death due to any cause.
Up to approximately 43 months
Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts
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.
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts
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.
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements, Reported as Adverse Events in Tumor-Specific Cohorts
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.
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
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.
FG002
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.
FG003
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.
FG004
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.
FG00012 subjects
FG00115 subjects
FG00235 subjects
FG00321 subjects
FG00418 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0025 subjects
FG0030 subjects
FG0041 subjects
NOT COMPLETED
FG00012 subjects
FG00113 subjects
FG00230 subjects
FG00321 subjects
FG00417 subjects
Type
Comment
Reasons
Death
FG00010 subjects
FG00113 subjects
FG00217 subjects
FG00312 subjects
FG0048 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0037 subjects
FG004
Reason not Specified
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG004
Safety Analysis Set included all participants who received any amount of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00115
BG00235
BG00321
BG00418
BG005101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG00235
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Japan
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Height
Number analyzed is the number of participants with data available for height at the Baseline.
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Weight
Number analyzed is the number of participants with data available for weight at the Baseline.
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Substance Use
Data for substance use was collected only for sqEC and sqNSCLC cohorts. Number analyzed is the number of participants with data available for substance use at Baseline.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Smoking Classification
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00115
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort
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.
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.
Posted
Number
percentage of participants
Cycle 1 (each cycle = 21 days)
ID
Title
Description
OG000
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.
Units
Counts
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG00050
Primary
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
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.
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.
Posted
Number
percentage of participants
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
ID
Title
Description
OG000
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.
Primary
Disease Control Rate (DCR) in Tumor-Specific Cohorts
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.
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.
Posted
Number
percentage of participants
From first dose up to end of treatment (Up to approximately 14 months)
ID
Title
Description
OG000
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.
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-931
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.
Posted
Mean
Standard Deviation
ng/mL
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931
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.
Posted
Median
Full Range
hour
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931
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.
Posted
Mean
Standard Deviation
h*ng/mL
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931
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.
Posted
Mean
Standard Deviation
h*ng/mL
Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
CLr: Renal Clearance of TAK-931
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.
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.
Posted
Mean
Standard Deviation
L/h
Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose
ID
Title
Description
OG000
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.
Units
Counts
Participants
Secondary
t1/2z: Terminal Disposition Phase Half-life for TAK-931
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.
Posted
Median
Full Range
hour
Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
CLss/F: Steady-state Apparent Oral Clearance for TAK-931
CL/F was defined as apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC.
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.
Posted
Mean
Standard Deviation
L/h
Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Rac(AUC): Accumulation Ratio Based on AUC Over the Dosing Interval (AUCτ) for TAK-931
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.
Posted
Mean
Standard Deviation
ratio
Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Overall Response Rate (CR and PR)
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.
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.
Posted
Number
percentage of participants
From first dose up to end of treatment (Up to approximately 14 months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Duration of Response (DOR)
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.
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.
Posted
Median
95% Confidence Interval
months
From first documented response until disease progression or end of treatment, whichever occurs first (Up to 14 months)
ID
Title
Description
OG000
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.
OG001
Pancreatic Cancer Cohort
Secondary
Progression Free Survival (PFS)
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.
Safety Analysis Set included all participants who received any amount of study drug.
Posted
Median
95% Confidence Interval
months
From date of randomization until disease progression or death, whichever occurs first (Up to approximately 34 months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Overall Survival (OS) in the Tumor-Specific Cohorts
OS was defined as the time from the date of first dose of study drug to death due to any cause.
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.
Posted
Median
95% Confidence Interval
months
Up to approximately 43 months
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Participants With Grade >=3 TEAEs, SAEs, TEAEs Leading to Dose Modifications, and TEAEs Leading to Treatment Discontinuation in Tumor-Specific Cohorts
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.
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.
Posted
Number
percentage of participants
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
ID
Title
Description
OG000
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.
Secondary
Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts
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.
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.
Posted
Number
percentage of participants
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements, Reported as Adverse Events in Tumor-Specific Cohorts
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.
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.
Posted
Number
percentage of participants
From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
ID
Title
Description
OG000
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.
OG001
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.
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)
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
10
12
7
12
5
12
EG001
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.
13
15
6
15
8
15
EG002
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.
17
35
8
35
27
35
EG003
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.
12
21
5
21
14
21
EG004
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.
8
18
3
18
14
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG0030 affected21 at risk
EG0040 affected18 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected15 at risk
EG0020 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0021 affected35 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected12 at risk
EG0015 affected15 at risk
EG00216 affected35 at risk
EG0037 affected21 at risk
EG0047 affected18 at risk
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0013 affected15 at risk
EG00214 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0012 affected15 at risk
EG0026 affected35 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected12 at risk
EG0011 affected15 at risk
EG0026 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0025 affected35 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0024 affected35 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 affected12 at risk
EG0012 affected15 at risk
EG0024 affected35 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0023 affected35 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0022 affected35 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood chloride decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood glucose increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Haematocrit decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Protein total decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected12 at risk
EG0012 affected15 at risk
EG0026 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0023 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0023 affected35 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected12 at risk
EG0015 affected15 at risk
EG0023 affected35 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0023 affected35 at risk
EG003
Early satiety
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected15 at risk
EG0023 affected35 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0011 affected15 at risk
EG0024 affected35 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected15 at risk
EG0023 affected35 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0012 affected15 at risk
EG0023 affected35 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0023 affected35 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0023 affected35 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0012 affected15 at risk
EG0024 affected35 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0024 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0011 affected15 at risk
EG0024 affected35 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0012 affected15 at risk
EG0020 affected35 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Candida infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected15 at risk
EG0022 affected35 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0022 affected35 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected15 at risk
EG0020 affected35 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected15 at risk
EG0020 affected35 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
Number of participants at risk in each arm is based on the female population in this study.
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected19 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00013
OG00131
OG00219
OG00317
Title
Denominators
Categories
Title
Measurements
OG00046.2(26.4 to 66.9)
OG00151.6(38.7 to 64.3)
OG00252.6(35.8 to 69.0)
OG00358.8(40.6 to 75.4)
OG002
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.
Units
Counts
Participants
OG00012
OG00115
OG00234
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
Title
Measurements
OG000173.61± 59.677
OG001204.69± 90.527
OG002185.46± 61.158
Cycle 1 Day 8
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
OG002
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.
Units
Counts
Participants
OG00012
OG00115
OG00234
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
Title
Measurements
OG0001.57(0.8 to 2.2)
OG0012.00(0.5 to 6.3)
OG0021.85(0.9 to 6.0)
Cycle 1 Day 8
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
OG002
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.
Units
Counts
Participants
OG00012
OG00115
OG00234
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
Title
Measurements
OG0001190.22± 540.877
OG0011166.40± 362.856
OG0021302.40± 391.035
Cycle 1 Day 8
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
OG002
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.
Units
Counts
Participants
OG00012
OG00115
OG00234
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
Title
Measurements
OG0001165.52± 552.287
OG0011114.23± 388.844
OG0021311.41± 388.557
Cycle 1 Day 8
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
Title
Measurements
OG000
OG000
4
Title
Denominators
Categories
Title
Measurements
OG0002.16± 1.913
OG002
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.
Units
Counts
Participants
OG00011
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG0005.95(4.3 to 6.7)
OG0015.53(3.7 to 8.0)
OG0026.18(4.8 to 8.4)
OG002
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.
Units
Counts
Participants
OG00011
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG00039.71± 14.135
OG00145.58± 18.877
OG00235.57± 10.778
OG002
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.
Units
Counts
Participants
OG00011
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG0001.27± 0.317
OG0011.10± 0.299
OG0021.12± 0.203
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00012
OG00113
OG00231
OG00319
OG00417
Title
Denominators
Categories
Title
Measurements
OG0008.3(0.90 to 28.7)
OG0010(0 to 16.2)
OG0020(0 to 7.20)
OG0035.3(0.60 to 19.0)
OG0040(0 to 12.7)
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0031
OG0040
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data for median; upper and lower limits of confidence interval (CI) were not available as all responders were censored.
OG003NA(NA to NA)Data for median; upper and lower limits of CI were not available as all responders were censored.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00012
OG00115
OG00235
OG00321
OG00418
Title
Denominators
Categories
Title
Measurements
OG0002.05(1.31 to 5.09)
OG0011.31(0.99 to 2.76)
OG0021.45(1.35 to 2.56)
OG0033.02(1.25 to 3.58)
OG0042.12(1.28 to 3.25)
OG002
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.
OG003
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.
Units
Counts
Participants
OG00015
OG00135
OG00221
OG00318
Title
Denominators
Categories
Title
Measurements
OG0004.67(1.77 to 7.06)
OG0017.72(5.68 to 11.96)
OG0028.61(3.94 to 42.71)
OG003NA(NA to NA)The median, upper and lower limits of 95% confidence interval were not evaluable due to fewer number of participants with events.
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00015
OG00135
OG00221
OG00318
Title
Denominators
Categories
Grade >=3 TEAEs
Title
Measurements
OG00073.3
OG00154.3
OG00257.1
OG00344.4
SAEs
Title
Measurements
OG00040.0
OG00122.9
OG00223.8
OG003
TEAEs Leading to Dose Modifications
Title
Measurements
OG00053.3
OG00148.6
OG00252.4
OG003
TEAEs Leading to Treatment Discontinuation
Title
Measurements
OG00013.3
OG0018.6
OG0029.5
OG003
OG002
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.
OG003
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.
Units
Counts
Participants
OG00015
OG00135
OG00221
OG00318
Title
Denominators
Categories
Neutrophil Count Decreased
Title
Measurements
OG00026.7
OG00117.1
OG00238.1
OG00327.8
White Blood Cell Count Decreased
Title
Measurements
OG00020.0
OG0018.6
OG00242.9
OG003
Lymphocyte Count Decreased
Title
Measurements
OG00013.3
OG0010
OG0020
OG003
Aspartate Aminotransferase Increased
Title
Measurements
OG0006.7
OG0012.9
OG0020
OG003
Alanine Aminotransferase Increased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Bilirubin Increased
Title
Measurements
OG0000
OG0012.9
OG0020
OG003
Hepatic Enzyme Increased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Creatinine Increased
Title
Measurements
OG00020.0
OG0010
OG0024.8
OG003
Blood Creatinine Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Urea Increased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Chloride Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Sodium Decreased
Title
Measurements
OG0000
OG0012.9
OG0020
OG003
Platelet Count Decreased
Title
Measurements
OG0000
OG0015.7
OG0024.8
OG003
Blood Alkaline Phosphatase Increased
Title
Measurements
OG0006.7
OG0015.7
OG0020
OG003
Blood Uric Acid Increased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Glucose Increased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Blood Albumin Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Protein Total Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Haematocrit Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
Red Blood Cell Count Decreased
Title
Measurements
OG0006.7
OG0010
OG0020
OG003
OG002
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.
OG003
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.