Table 1.

Summary of pevonedistat clinical studies included in the population pharmacokinetics analysis

Study	NCT	Cancer type	n	Pevonedistat regimen	Pevonedistat doses	Pevonedistat treatment schedule	Pharmacokinetic sampling	Total number samples per study
C15001	NCT00677170	Solid tumour	60	Single agent	25–196 mg/m2	Once per day for 5 days	Day 1—predose, end of infusion, 30 min, 1, 2, 4, 8 h postinfusion; day 2—predose, end of infusion; day 5—predose, end of infusion, 30 min, 1, 2, 4, 6, 10, 24, 72, 120 h postinfusion	849
C15002	NCT00722488	Haematological	56	Single agent	25–261 mg/m2	Cycle 1—days 1, 2, 8, 9	Day 1—predose, end of infusion, 30 min, 1, 2, 4, 8 h postinfusion; day 2—predose, end of infusion; day 8—predose, end of infusion; day 9—predose, end of infusion, 30 min, 1, 2, 4, 6, 9, 24, 72, 144 h postinfusion	850
C15003	NCT00911066	Haematological	72	Single agent	25–83 mg/m2	Cycle 1—days 1, 3, 5	Day 1—predose, end of infusion, 30 min, 1, 2, 4, 8, 24 h postinfusion; day 3—predose; day 5—predose, end of infusion, 3 to 6 h postinfusion	571
C15005	NCT01011530	Solid tumour	36	Single agent	50–278 mg/m2	Days 1, 4, 8, 11	Day 1—predose, end of infusion, 30 min, 1, 4, 7 h postinfusion; day 2–24 h; day 3–48 h; day 4—predose, end of infusion, 3 to 6 h; day 8—predose, end of infusion, 4, 7 h; day 11—predose, end of infusion, 4, hours; day 15 (at clinic visit).	337
C15009	NCT01814826	Haematological	64	Combination with azacitidine	20, 30, 40, 50 mg/m2	Days 1, 3, 5	Day 1—predose, end of infusion, 1, 2, 4, 6 h postinfusion; day 2–24 h postinfusion; day 3—predose; day 5—predose, end of infusion, 1, 2, 4, 6 h postinfusion; day 6–24 h postinfusion; day 7–48 h postinfusion	831
C15010	NCT01862328	Solid tumour	58	Combination with docetaxel (arm 1), carboplatin + paclitaxel (arm 2), gemcitabine (arm 3)	15, 25, 37, 50 mg/m2	Days 1, 3, 5	Day 1—predose, end of infusion, 1.5, 3 h postdose; day 2–20 h postdose; day 3—predose	330

Data are presented for the 335 evaluable subjects with observed pharmacokinetic data.