TABLE 4.
Dose levels and dose limiting toxicities (DLTs)
| Dose level | Talazoparib | Carboplatin (AUC) | Paclitaxel (mg/m2) | Enrolled (N) | Evaluable (N) | # Patients with DLTs | DLTs |
|---|---|---|---|---|---|---|---|
| A/Level 1 | 250mcg D1‐7 | 5 | 80 | 5 | 3 | 0 | |
| A/Level 2 | 250mcg D1‐7 | 6 | 80 | 15 | 12 | 2 a |
Pt 1: G3 neutropenia Pt 2: G4 neutropenia |
| A/Level 3 | 350mcg D1‐7 | 6 | 80 | 3 | 3 | 2 |
Pt 1: G3 febrile neutropenia Pt 2: G3 neutropenia |
| B/Level 1 | 250mcg D1‐3 | 6 | 80 | 14 | 11 | 3 a |
Pt 1: G3 neutropenia Pt 2: G3 neutropenia Pt 3: G3 neutropenia |
| B/Level 2 | 350mcg D1‐3 | 6 | 80 | 6 | 6 | 2 |
Pt 1: G3 febrile neutropenia, G4 neutropenia, G4 thrombocytopenia Pt 2: G4 neutropenia |
a
DLTs occurred in the dose expansion cohort.