Table 2.
Dose Escalation and Response Table
| Dose Level | Veliparib (mg)* | Topotecan (mg/m2) | Number of patients treated | Mutation Status | Number of DLTs | Responses | |||
|---|---|---|---|---|---|---|---|---|---|
| CR | PR | SD | PD | ||||||
| 1 | 10 qd | 2 | 3 | BRCA1 | 0 | 0 | 0 | 2 | 1 |
| 2 | 20 qd | 2 | 3 | BRCA2 | 0 | 0 | 1 | 0 | 1 |
| 3 | 10 qd | 3 | 3 |
BRCA1 CHEK2 |
0 | 0 | 0 | 1 | 1 |
| 4 | 20 qd | 3 | 3 | BRCA1 (2) | 0 | 0 | 0 | 2 | 1 |
| 5 | 20 qd | 4 | 6 |
BRCA1 (2) RAD51D MSH6 |
3 | 1 | 0 | 4 | 1 |
| 6 | 30 qd | 4 | 6 | BRCA1 | 2 | 0 | 0 | 3 | 3 |
| 7** | 30 bid | 3 | 3 | BRCA1 | 0 | 0 | 0 | 3 | 0 |
| 8 | 50 bid | 3 | 3 | BRCA1 | 0 | 0 | 0 | 1 | 2 |
| 9 | 100 bid | 3 | 3 | BRCA1 | 0 | 0 | 0 | 1 | 2 |
| 10 | 150 bid | 3 | 6 | FANCL | 1 | 0 | 0 | 3 | 2 |
| 11 | 200 bid | 3 | 3 | 0 | 0 | 0 | 2 | 1 | |
| 12 (MTD) | 300 bid | 3 | 6 | BRCA1 | 1 | 0 | 3 | 0 | 2 |
| 13 | 400 bid | 3 | 3 | BRCA1 | 2 | 0 | 0 | 0 | 2 |
*
Abbreviations are:qd, one a day; bid, twice a day.
**
Dose level 7 and higher received twice daily veliparib