Table 4 Pharmacokinetic parameters of RO4929097 at different DLs

From: A phase I study of the combination of ro4929097 and cediranib in patients with advanced solid tumours (PJC-004/NCI 8503)

 

DL-1 (RO4929092=10 mg)

(n : 5)

DL-2 (RO4929092=20 mg)

(n : 7)

DL-3 (RO4929092=20 mg)

(n : 5)

Total RO4929097

Day 1

Day 10

Day 22

Day 1

Day 10

Day 22

Day 1

Day 10

Day 22

T max, h

Median

2

2

2

2

1

1

4

2

2

Range

1–2

1–4

1–24

0.5–24

0.5–24

1–24

0.5–6

0.5–4

1-2

C max, nmoll−1

Mean

296.4

296

288.6

465.14

778.85

482

437.8

788.2

408

s.d.

178.6

176.93

106.22

125.55

385.82

244.74

273.73

230.63

172.83

AUC t ng*hml−1

Mean

2678.07

3441.80

3547.46

5367.68

11237.66

6360.44

7467.97

12164.95

6085.72

s.d.

1445.30

3025.29

1661.92

3374.58

7663.55

3919.95

5368.38

3688.61

2536.22

 

DL-1

DL-2

DL-3

Unbound RO4929097

Day 1

Day 10

Day 22

Day 1

Day 10

Day 22

Day 1

Day 10

Day 22

C max, nmoll−1

Mean

18.06

21.44

16.48

42.57

63.34

37.42

32.48

53.52

25.68

s.d.

9.99

10.34

5.91

10.21

22.26

18.46

19.85

21.77

12.77

  1. Abbreviation: DL=dose level.