Patient enrollment by dose level and phase of study
Schedule . | dose, mg/m2 . | Phase 1, n . | Phase 2, n . | Total, N . |
---|---|---|---|---|
QW | 0.7* | 3* | — | 9* |
1.0* | 3* | — | ||
1.3* | 3* | — | ||
1.6 | 6† | 12 | 18 | |
BIW | 0.7* | 3* | — | 9* |
1.0* | 6* | — | ||
1.3 | 7‡ | 27 | 34 | |
Total | 31 | 39 | 70 |
Schedule . | dose, mg/m2 . | Phase 1, n . | Phase 2, n . | Total, N . |
---|---|---|---|---|
QW | 0.7* | 3* | — | 9* |
1.0* | 3* | — | ||
1.3* | 3* | — | ||
1.6 | 6† | 12 | 18 | |
BIW | 0.7* | 3* | — | 9* |
1.0* | 6* | — | ||
1.3 | 7‡ | 27 | 34 | |
Total | 31 | 39 | 70 |
BIW indicates twice-weekly schedule; QW, once-weekly schedule; and —, not applicable.
Patients treated at doses lower than the recommended (maximum planned) doses on each schedule, which were evaluated in the phase 2 portion of the trial.
One patient experienced a dose-limiting toxicity of grade 3 restrictive cardiomyopathy.
One patient experienced a dose-limiting toxicity of grade 3 congestive cardiac failure.