{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}],"title":"Complete response (CR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}],"title":"Partial response (PR)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"7"}],"title":"Stable disease (SD)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"}],"title":"Non-complete response/non-partial response (non-CR/non-PR)"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"8"}],"title":"Progressive disease (PD)"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"2"}],"title":"Not evaluable (NE)"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"18"},{"groupId":"OG006","value":"13"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"6"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"17"}],"units":"Participants"}],"description":"Objective response is defined as the proportion of participants who achieved a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; at least a 30% decrease from baseline in the sum of diameters of target lesions) per RECIST version 1.1.","groups":[{"description":"Patients who received doses at 25 mg once daily under fasted conditions.","id":"OG000","title":"Dose Escalation 25 mg QD"},{"description":"Patients who received doses at 50 mg once daily under fasted conditions.","id":"OG001","title":"Dose Escalation 50 mg QD"},{"description":"Patients who received doses at 100 mg once daily under fasted conditions.","id":"OG002","title":"Dose Escalation 100 mg QD"},{"description":"Patients who received doses at 200 mg once daily under fasted conditions.","id":"OG003","title":"Dose Escalation 200 mg QD"},{"description":"Patients who received 400 mg once daily under fasted conditions.","id":"OG004","title":"Dose Escalation 400 mg QD"},{"description":"Patients who received 800 mg once daily under fasted conditions.","id":"OG005","title":"Dose Escalation 800 mg QD"},{"description":"Patients who received 800 mg once daily under not fasted conditions.","id":"OG006","title":"Dose Escalation 800 mg QD NF"},{"description":"Patients who received 1000 mg once daily under fasted conditions.","id":"OG007","title":"Dose Escalation 1000 mg QD"},{"description":"Patients who received 1200 mg once daily under fasted conditions.","id":"OG008","title":"Dose Escalation 1200 mg QD"},{"description":"Patients who received 400 mg twice daily under not fasted conditions.","id":"OG009","title":"Dose Escalation 400 mg BID"},{"description":"Patients who received 600 mg twice daily under not fasted conditions.","id":"OG010","title":"Dose Escalation 600 mg BID"},{"description":"Patients who received 800 mg twice daily under fasted conditions.","id":"OG011","title":"Dose Escalation 800 mg BID"},{"description":"Safety expansion patients who received 800 mg once daily under not fasted conditions.","id":"OG012","title":"Safety Expansion 800 mg QD"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Assessed until disease progression or death for up to 12 months","title":"Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity","type":"SECONDARY","unitOfMeasure":"Participants"}