Table 1.
Dose Level | Veliparib (mg AM/PM) | Enrolled mut/wt | Evaluable mut/wt | DLT mt/wt | Grade – DLT** |
---|---|---|---|---|---|
1 | 50/50 | 7/3 | 7/3 | 1*/0 | Grade 2 thrombocytopenia, later deemed related to disease progression, necessitated hold of veliparib > 2 weeks |
2 | 100/50 | 3/3 | 3/3 | ||
3 | 100/100 | 3/3 | 3/3 | ||
4 | 150/100 | 3/3 | 3/3 | ||
5 | 150/150 | 3/3 | 3/3 | ||
6 | 200/200 | 4/3 | 3/3 | ||
7 | 300/300 | 6/3 | 4/3 | ||
8 | 400/400 | 34/7 | 27/6 | 1/1 | G3 nausea / G2 seizure |
9 | 500/500 | 7/0 | 6/0 | 1/0 | G2 seizure |
DLT experienced before start of parallel enrollment of BRCAmt and BRCAwt cohorts.
Per protocol, any seizure occurring in a patient on this study was considered a DLT, unless in the setting of CNS metastases.