Table 2.
Dose Levels and Dose-limiting Toxicities (DLTs).
Dose Level | Veliparib Dose (mg BID) |
Carboplatin Dose (AUC) |
Paclitaxel Dose (mg/m2) |
# Enrolled | # Evaluable for DLT |
DLTs |
---|---|---|---|---|---|---|
Level 1 | 10 | 6 | 150 | 5 | 3 | 0 |
Level 2 | 20 | 6 | 150 | 8 | 7 | Grade 3 neutropenia > 7 days |
Level 3 | 20 | 6 | 175 | 3 | 3 | 0 |
Level 4 | 40 | 6 | 175 | 3 | 3 | 0 |
Level 5 | 40 | 6 | 200 | 13 | 6 | Grade 3 febrile neutropenia |
Level 6 | 50 | 6 | 200 | 5 | 3 | 0 |
Level 7 | 80 | 6 | 200 | 11 | 6 | Grade 3 febrile neutropenia |
Level 7B | 100 | 6 | 200 | 15 | 14 | Grade 4 sepsis and neutropenia Grade 4 neutropenia Grade 4 febrile neutropenia and Grade 3 fatigue |
Level 8 | 120 | 6 | 200 | 10 | 7 | Grade 4 hyponatremia, Grade 3 nausea Grade 3 febrile neutropenia |