Table 4a. Mean (s.d.) pharmacokinetic parameters of total and unbound cisplatin, with or without tipifarnib (100–300 mg).
| Variable | Units | Gem/cis (s.d.) n=24 | gem/cis+tipifarnib (s.d.) n=30 | P-valuea |
|---|---|---|---|---|
| Total cisplatin | ||||
| Median tmax | Hours | 3.19 | 3.28 | – |
| Cmaxb | μg ml−1 | 4.72 (1.68) | 4.29 (0.78) | 0.124c |
| AUC0-23b | h μg ml−1 | 63.0 (8.93) | 61.6 (9.78)d | 0.575c |
| t1/2 | Hours | 40.6 (13.2)e | 46.1 (18.4)c | — |
| Unbound cisplatin | ||||
| Median tmax | Hours | 3.03 | 3.02 | — |
| Cmaxb | μg ml−1 | 1.91 (1.77) | 1.59 (0.24) | 0.898c |
| AUC0-23b | h μg ml−1 | 6.84 (3.06) | 5.80 (1.93)f | 0.272g |
| t1/2 | Hours | 9.01 (8.78)h | 6.65 (18.2)i | — |
| Pt-AG | ||||
| AUA0-23b | fmol h μg−1 | 2.78j | 2.66g | 0.769k |
| Pt-GG | ||||
| AUA0-23b | fmol h μg−1 | 16.70g | 18.52g | 0.715k |
a
Two-sided P-value for testing a difference between the two treatments. Only data from patients who completed the study were included.
b
Parameter values adjusted to 75 mg m−2 dose of cisplatin.
c
n=24.
d
n=29.
e
n=17.
f
n=28.
g
n=23.
h
n=12.
i
n=16.
j
n=22.
k
n=15.
Gem=gemcitabine; cis=cisplatin.