Table 2.
Treatment exposure and reasons for study treatment discontinuation
| Part 1 MR | Part 2 MRV | ||||
|---|---|---|---|---|---|
| Alisertib dose, mg | 50 b.i.d. (n = 13) | 30 b.i.d. (n= 4) | 40 b.i.d.a (n= 25) | 50 b.i.d. (n= 3) | Total (n = 32) |
| Median cycles of alisertib, n (range) | 4 (1–54) | 2 (1–15) | 4 (1–31) | 3 (1–5) | 3 (1–31) |
| Median duration of treatment, days (range) | 70 (7–1,218) | 28 (7–328) | 69 (5–638) | 77 (6–126) | 62.5 (5–638) |
| atients receiving ≥8 cycles, n (%) Primary reason for study treatment discontinuation, n |
3 (23) | 1 (25) | 8 (32) | 0 | 9 (28) |
| PD | 10 | 3 | 10 | 1 | 14 |
| AE | 0 | 1 | 4 | 1 | 6 |
| Symptomatic deterioration | 2 | 0 | 4 | 0 | 4 |
| Voluntary withdrawal | 0 | 0 | 3 | 1 | 4 |
| Ongoing on study treatment, n | 1 | 0 | 4 | 0 | 4 |
Abbreviations: AE, adverse event; b.i.d., twice daily; MR, alisertib plus rituximab; MRV, alisertib plus rituximab plus vincristine; PD, progressive disease; RP2D, recommended phase II dose.
a
RP2D.