Table III.
Summary of PK parameters for navitoclax and rituximab concentration levels (pooled data from arms A and B)*.
| Navitoclax dose (visit) | n | Tmax (h) | Cmax (μg/mL) | AUC (h*μg/mL) |
|---|---|---|---|---|
| 100 mg (lead-in day 5) | 39 | 6.0 (3.6-8.0) | 2.3 ± 0.9 | 10.5 ± 4.1 |
| 250 mg (week 8, day 1) | 28 | 6.1 (2.0-8.0) | 3.7 ± 2.0 | 61.2 ± 31.2 |
| Week 8 mean ± SD rituximab concentration (μg/mL) |
||
|---|---|---|
| Pre-infusion | Post-infusion | |
| Arm A: rituximab | 296 ± 175 (n = 33) | 576 ± 264 (n = 33) |
| Arm B: rituximab + ABT-263 | 296 ± 100 (n = 33) | 553 ± 145 (n = 31) |
| Arm C: rituximab + ABT-263 to PD | 323 ± 116 (n = 35) | 572 ± 161 (n = 31) |
PK, pharmacokinetics; PD, progressive disease; Tmax, time to maximum concentration; Cmax, maximum concentration; AUC, area under the curve; SD, standard deviation.
*
Tmax presented as median (range); Cmax and AUC as mean ± SD; AUC on lead-in day 5 is AUC(0-8 h) and on week 8, day 1 is AUC(0-24 h).