Study drug exposure
PID
The median duration of exposure for the 3 mg dose cohort was 3.7 months (range: 0.5–28.1) with a median of 4.0 cycles (range: 1–31). The median duration of exposure for the 5 mg dose cohort was 3.5 months (range: 0.6–11.3) with a median of 4.0 cycles (range: 1–11). Six patients, 3 (42.9%) in the 3 mg dose cohort and 3 (23.1%) in the 5 mg dose cohort, received > 6 cycles of treatment with fruquintinib. The median percentage-intended dose (PID) (defined as 100% times the duration [days] of receiving any dose of fruquintinib divided by the total duration [days] of exposure, calculated as last dose date of study drug – first dose date of study drug + 8 days) in the 3 mg dose cohort was 71.9% (range: 50.0%-74.3%). Given the 3/1 dosing schedule on a 28-day cycle, the reference value of PID is 75%. The median PID in the 5 mg dose cohort was 65.5% (range: 21.1%-75.9%). Four (57.1%) and 9 (69.2%) patients experienced dose interruption for the 3 and 5 mg dose cohorts, respectively.