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Table 6 Pharmacokinetic parameters of PR104 metabolites

From: PR-104 a bioreductive pre-prodrug combined with gemcitabine or docetaxel in a phase Ib study of patients with advanced solid tumours

 

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

Historical data for PR104 alone [8, 16]

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