Table 1

Patient enrollment by dose level and phase of study

Scheduledose, mg/m2Phase 1, nPhase 2, nTotal, 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 
Scheduledose, mg/m2Phase 1, nPhase 2, nTotal, 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.

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