Table 6

Mean AUC0-∞ (log-linear estimations) by cohort and dose level

CohortAUC0-∞, mean ± SD (μM × h)PatientsDose level, mg/m2AUC0-∞, mean ± SD (μM × h)Profiles
10.0 ± 5.6 20 30 + 30 10.4 ± 4.6 55 
 (9.0 ± 2.9)* (19)  (10.0 ± 3.7)* (54) 
9.0 40 + 40 9.0 
11.4 ± 3.9 19 30 + 50 12.9 ± 3.7 28 
12.1 ± 2.4 16    
CohortAUC0-∞, mean ± SD (μM × h)PatientsDose level, mg/m2AUC0-∞, mean ± SD (μM × h)Profiles
10.0 ± 5.6 20 30 + 30 10.4 ± 4.6 55 
 (9.0 ± 2.9)* (19)  (10.0 ± 3.7)* (54) 
9.0 40 + 40 9.0 
11.4 ± 3.9 19 30 + 50 12.9 ± 3.7 28 
12.1 ± 2.4 16    

Data for cohorts includes initial and escalated doses for all 58 patients (including re-enrolled patients).

*

Means without the outlier patient 6.

Comparison of AUC0-∞ for all 30+30 and 30+50 doses, P = .002.

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