Table 1

Lestaurtinib trough plasma levels and FLT3 inhibitory activity from day 15 samples of AML15 versus Cephalon 204 trial patients

Cephalon 204 trialAML15 trial
No. of samples 78 18 
Lestaurtinib, μM (mean) 12.3 16.4* 
Mean FLT3 activity, % baseline, all patients (range) 17.9 (0.8-76.9) 3.0 (0-74.6) 
% FLT3 inhibited (n/N) 59 (46/78) 100 (18/18) 
α1-acid glycoprotein, mg/dL (range) 181 (92-287) 224§ (90-450) 
Cephalon 204 trialAML15 trial
No. of samples 78 18 
Lestaurtinib, μM (mean) 12.3 16.4* 
Mean FLT3 activity, % baseline, all patients (range) 17.9 (0.8-76.9) 3.0 (0-74.6) 
% FLT3 inhibited (n/N) 59 (46/78) 100 (18/18) 
α1-acid glycoprotein, mg/dL (range) 181 (92-287) 224§ (90-450) 

All patients received 80 mg twice-daily lestaurtinib, started after completion of chemotherapy (which began on day 1). Mean FLT3 activity represents the mean of values obtained from the PIA assay for these time points for all 78 samples. Percentage FLT3 inhibited refers to the percentage of patients for whom FLT3 was inhibited to less than the target of ≤ 15% of baseline.

*

P = .102.

P = .0004.

P < .0001.

§

P < .0001.

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