Table 1.
Patient characteristics.
| Arm A | Arm B | Arm C | Arm D | Total | |
|---|---|---|---|---|---|
| (N = 8) | (N = 24) | (N = 14) | (N = 30) | (N = 76) | |
| Selinexor Dose | 50 mg/m2 BIW (n = 7), 60 mg BIW (n = 1)c | 50 mg/m2 BIW | 60 mg BIW | 80 mg QW | |
| Age (years)a, median (range) | 58.0 (43–65) | 50.5 (29–69) | 52.0 (27–65) | 56 (21–78) | 56 (20–78) |
| Sex, n (%) | |||||
| Male | 7 (87.5) | 19 (79.2) | 9 (64.3) | 19 (63.3) | 54 (71.1) |
| Female | 1 (12.5) | 5 (20.8) | 5 (35.7) | 11 (36.7) | 22 (28.9) |
| Prior lines of therapyb, median (range) | 1.5 (1–2) | 1 (1–2) | 1 (1–3) | 1 (1–8) | 1 (1–8) |
| Baseline Karnofsky Performance Status, n (%) | |||||
| ≤80% | 5 (62.5) | 9 (37.5) | 5 (35.7) | 14 (46.7) | 33 (43.4) |
| >80% | 3 (37.5) | 15 (62.5) | 15 (62.5) | 16 (53.3) | 43 (56.6) |
Note: Arm A was primarily designed to determine intratumoral pharmacokinetics, and arms B–D tested efficacy of different dose schedules.
Abbreviations: BIW, twice per week; QW, once per week.
aAt time of first dose.
bData missing for two patients in Arm C and one patient in Arm D.
cPatient treated after protocol update in version 4.0 in which the dose was changed to 60 mg flat.