Table 1.
Dosing allocation and outcomes
| All subjects 20-100 VEN (cycle 0) |
IBR (week 1+) mg per day | |||
|---|---|---|---|---|
| 280 | 420 | 560 | ||
| VEN (mg per day) |
400 (week 3+) 200 (week 2) 100 (week 1) |
Zone 2/arm C (n = 8) ORR 6/8 CR 4/8 PD on Rx 2/8 DLT 0/8 Dose Mods†: 8/8 |
Zone 3/arm E (n = 5) (1 not evaluable) ORR 3/4 CR 2/4 PD on Rx 2/4 DLT 2/5 Dose Mods†: 2/5 |
Zone 4/arm F (n = 0) |
|
200 (week 3+) 200 (week 2) 100 (week 1) |
Zone 1/arm A (n = 2) ORR 2/2 CR 1/2 PD on Rx 0/2 DLT 0/2 Dose Mods†: 2/2 |
Zone 2/arm B (n = 16) ORR 15/16 CR 6/15* PD on Rx 2/16 DLT 1/16 Dose Mods†: 6/16 |
Zone 3/arm D (n = 4) ORR 2/4 CR 1/4 PD on Rx 2/4 DLT 0/4 Dose Mods†: 3/4 |
|
*
One subject had a response but could not be evaluated for CR status.
†
Dose modifications or holds.