Table 2. Patient Dosing and DLT Assessment.
Dose Cohort | ABT-888 (mg days 5-21 of cycle 1 and 1-21 of subsequent cycles) | XRT (cGy days 1 and 5 weeks 1-3 for 3 cycles*) | N | Median no of Completed Cycles (range) | DLT |
---|---|---|---|---|---|
1 | 40mg BID | 60 cGy | 3 | 2.66 (2-3) | 0 |
2 | 80mg BID | 60 cGy | 6 | 2.16 (0-3) | **1 |
3 | 120mg BID | 60 cGy | 6 | 2.00 (1-3) | 0 |
4 | 160mg BID | 60 cGy | 7 | 1.71 (1-3) | 0 |
Cycle is 28 days
Grade 2, protracted thrombocytopenia. By the original protocol, this would not have met requirement for DLT. However, this was considered a DLT at the discretion of the principle investigators.