| PR104 Dose | Patients | AUC/PR-104 dose (100*h.m2.L-1)a | ||||
---|---|---|---|---|---|---|---|
Level | mg/m2 | (n) | PR104G | PR104H | PR-104M | PR-104S1 | |
Group A PR104 + gemcitabine | 1 | 140 | 3 | 1.51 ± 0.63 | 0.12 ± 0.02 | 0.022±0.002 | 0.021±0.006 |
2 | 275 | 6 | 1.18 ± 0.30 | 0.16 ± 0.03 | 0.015±0.002 | 0.020±0.006 | |
Group B PR104 + docetaxel 60 | 1 | 200 | 3 | 0.86 ± 0.29 | 0.20 ± 0.06 | 0.016±0.003 | 0.010±0.003 |
2 | 400 | 3 | 1.63 ± 0.73 | 0.12 ± 0.03 | 0.016±0.002 | 0.042±0.022 | |
Group C PR104 + docetaxel 60 + GCSF | 1 | 200 | 3 | 0.47 ± 0.26 | 0.07 ± 0.01 | 0.021±0.003 | 0.022±0.004 |
2 | 400 | 3 | 1.75 ± 0.57 | 0.11 ± 0.03 | 0.012±0.001 | 0.017±0.002 | |
3 | 550 | 3 | 1.56 ± 0.38 | 0.16 ± 0.04 | 0.025±0.007 | 0.045±0.012 | |
4 | 770 | 6 | 2.56 ± 0.67 | 0.07 ± 0.01 | 0.012±0.002 | 0.062±0.019 | |
5 | 1100 | 6 | 2.76 ± 1.68 | 0.09 ± 0.01 | 0.010±0.001 | 0.019±0.030 | |
Group D PR104 + docetaxel 75 + GCSF | 1 | 770 | 6 | 1.16 ± 0.18 | 0.035 ± 0.005 | 0.009±0.001 | 0.022±0.006 |
n/a | 675 | 7 | 1.02 ± 0.24 | 0.06 ± 0.01 | 0.011 ± 0.002 | 0.042 ± 0.015 | |
 | 1100 | 10 | 2.35 ± 0.85 | 0.09 ± 0.01 | 0.015± 0.002 | 0.041 ± 0.009 |