{"groups":[{"description":"TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.","id":"FG000","title":"Western Safety Cohort"},{"description":"TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.","id":"FG001","title":"Pancreatic Cancer Cohort"},{"description":"TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.","id":"FG002","title":"Metastatic CRC Cohort"},{"description":"TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.","id":"FG003","title":"sqEC Cohort"},{"description":"TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.","id":"FG004","title":"sqNSCLC Cohort"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"12"},{"groupId":"FG004","numSubjects":"8"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"7"},{"groupId":"FG004","numSubjects":"5"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"3"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"18"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"30"},{"groupId":"FG003","numSubjects":"21"},{"groupId":"FG004","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"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.","recruitmentDetails":"Participants took part in the study at 12 investigative sites in Japan and the United States from 25 October 2017 to 24 August 2020."}