Table 2. Dose escalation, dose-limiting toxicities, and response.
| Dose | Schedule | Number of patients | Number of DLT-evaluable patientsa | DLTs | Response |
|---|---|---|---|---|---|
| 300 mg | q2w | 4 | 3 | 0 | 0 |
| 600 mg | q2w | 5 | 3 | 0 | 0 |
| 1200 mg | q2w | 7 | 4 | 0 | 1 CRp, 1 PR |
| 2400 mg | q2w | 5 | 5 | 0 | 0 |
| 1200 mg | Weekly | 9 | 3 | 0 | 0 |
| 600 mg | Twice weekly | 4 | 3 | 0 | 1 HI |
| 1200 mgb | Twice weekly | 10 | 5 | 1 | 0 |
Abbreviations: CRp, complete response with incomplete platelet recovery; DLT, dose-limiting toxicity; HI, hematologic improvement; MTD, maximum tolerated dose; PR, partial response; PK, pharmacokinetics.
a
Evaluable patient is defined as any treated patient who previously had a DLT and/or completed the DLT period without having a subsequent DLT.
b
At study termination, only one DLT occurred in this cohort out of the 5 evaluable patients; no additional patients were included and the MTD was not determined.