{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"8"}]}],"title":"Response rate (RR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"19"},{"groupId":"OG004","value":"19"}]}],"title":"Disease control rate (DCR)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"24"},{"groupId":"OG004","value":"25"}],"units":"Participants"}],"description":"Response rate (RR): Proportion of subjects whose best overall response is CR or PR.\n\nDisease control rate (DCR): Proportion of subjects whose best overall response is CR, PR or SD.\n\nThe result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.","groups":[{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG000","title":"NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)"},{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG001","title":"MPM: BBI608 + Pem +CDDP (Phase 1 Part)"},{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG002","title":"MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)"},{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG003","title":"MPM: BBI608 + Pem + CDDP (Phase 2 Part)"},{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG004","title":"MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).","reportingStatus":"POSTED","timeFrame":"From BBI608 administration to death from any cause, about 17 months","title":"Response Rate (RR) and Disease Control Rate (DCR)","type":"SECONDARY","unitOfMeasure":"Participants"}