Table 1.
Dose cohorts and adverse events of at least grade 2, at least possibly related to study medication
| Dose level | Veliparib (QD) | Cyclophosphamide (QD × 21 days) | Total No. of patients | Adverse event | Gradea | No. of patients |
|---|---|---|---|---|---|---|
| 1 | 20 mg × 7 days | 50 mg | 3 | Lymphopenia | 2 | 1 |
| 3 | 1 | |||||
| 2 | 30 mg × 7 days | 50 mg | 3 | Lymphopenia | 2 | 2 |
| Leucopenia | 2 | 1 | ||||
| Neutropenia | 2 | 2 | ||||
| Thrombocytopenia | 2 | 1 | ||||
| 3 | 30 mg × 14 days | 50 mg | 3 | Lymphopenia | 2 | 2 |
| Leucopenia | 2 | 1 | ||||
| Anemia | 2 | 1 | ||||
| 4 | 40 mg × 21 days | 50 mg | 3 | Lymphopenia | 2 | 1 |
| 3 | 1 | |||||
| Leucopenia | 2 | 1 | ||||
| Neutropenia | 2 | 1 | ||||
| Allergic reaction | 2 | 1 | ||||
| 5 | 40 mg × 21 days | 100 mg | 3 | Lymphopenia | 2 | 1 |
| 3 | 2 | |||||
| Fatigue | 3 | 1 | ||||
| 6 | 50 mg × 21 days | 50 mg | 3 | Lymphopenia | 3 | 2 |
| Leucopenia | 2 | 1 | ||||
| 7 | 60 mg × 21 days | 50 mg | 14 | Lymphopenia | 2 | 2 |
| 3 | 3 | |||||
| 4 | 3 | |||||
| Leucopenia | 2 | 4 | ||||
| Neutropenia | 2 | 2 | ||||
| Anemia | 2 | 4 | ||||
| Thrombocytopenia | 2 | 2 | ||||
| Fatigue | 2 | 2 | ||||
| Hypophosphatemia | 3 | 1 | ||||
| Hypoalbuminemia | 2 | 1 | ||||
| Nausea | 2 | 1 | ||||
| Vomiting | 2 | 1 | ||||
| Upper respiratory infection | 2 | 1 | ||||
| Urinary tract infection | 2 | 1 | ||||
| Urinary tract obstruction | 3 | 1 | ||||
| 8 | 80 mg × 21 days | 50 mg | 3 | Lymphopenia | 2 | 1 |
| Leucopenia | 2 | 1 | ||||
| Neutropenia | 2 | 1 | ||||
| Acute respiratory failure | 4 | 1b | ||||
| Abdominal distension, abdominal pain | 3 | 1b |
a
Worst grade reported per patient.
b
Dose-limiting toxicity. The patient with acute respiratory failure died; the treating physician felt the cause of death was likely disease progression, but the possibility that the study drug combination may have contributed to the respiratory failure could not be excluded.
Abbreviation: QD, once a day.