Table 2.
Treatment by dose level
| Dose Level | Triapine 24-hours i.v. Infusion (mg) |
Gemcitabine i.v., Fixed-Dose-Rate (mg/m2) |
No. of Patients |
No. with DLTa |
No. with DRb or DDc |
Description of DLTs |
|---|---|---|---|---|---|---|
| −2A | 75 | 1000 | 1 | 1 | 1 | Neutropenia, Thrombocytopenia |
| −1A | 90 | 1000 | 5 | 2 | 4 | Neutropenia, Leukopenia, Thrombocytopenia |
| 1A | 120 | 1000 | 5 | 2 | 4 | Neutropenia, Leukopenia, Thrombocytopenia |
| 2A | 160 | 1000 | 2 | 2 | 2 | Neutropenia, Fatigue & Dyspnea (Grade 3) |
| 1B | 75 | 1000 | 6 | 1 | 4 | Neutropenia |
| 2Bd | 90 | 1000 | 15 | 1 | 8 | Thrombocytopenia |
| 3B | 120 | 1000 | 2 | 2 | 1 | Neutropenia, Leukopenia, Infection (Grade 3) |
a
DLT: Dose limiting toxicity
b
DR: Dose reduction
c
DD: Dose delay
d
Including expansion cohort of 6 patients at this dose level
A: Arm A of the study, during which, both drugs were given on days 1 and 8 of a 21-day cycle regimen
B: Arm B of the study, during which, both drugs were given on days 1 and 15 of a 28-day cycle regimen