A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas
Table 4
Pharmacokinetic parameters of belinostat (Bel) following administration of Bel alone (cycle 1 day 4) or in combination with doxorubicin (cycle 1 day 5).
Occasion
600 mg/m2 Bel + 50 mg/m2 doxorubicin
600 mg/m2 Bel + 75 mg/m2 doxorubicin
800 mg/m2 Bel + 75 mg/m2 doxorubicin
1000 mg/m2 Bel + 75 mg/m2 doxorubicin
Day 4
Day 5
Day 4
Day 5
Day 4
Day 5
Day 4
Day 5
()
()
()
()
()
()
()
()
(ng⋅h/mL)
10900 (16.2)
10400 (22.3)
9670 (40.0)
10400 (24.7)
12200 (28.5)
14600 (26.0)
23100 (35.4)
22100 (43.2)
(ng/mL)
21100 (13.6)
18300 (36.2)
16800 (69.2)
17400 (45.1)
21400 (44.9)
26400 (30.0)
41100 (35.0)
37000 (59.1)
(h)
0.533 (0.500–0.550)
0.567 (0.550–0.583)
0.567 (0.500–0.783)
0.517 (0.467–0.667)
0.533 (0.500–0.583)
0.533 (0.483–0.583)
0.617 (0.500–0.750)
0.633 (0.517–1.60)
(h)
24.5 (22.4–24.6)
17.0 (17.0–20.1)
24.0 (8.55–24.5)
24.5 (16.2–24.7)
23.7 (8.47–24.6)
15.1 (8.50–24.6)
8.65 (1.05–24.0)
8.72 (8.50–24.7)
(norm)
18.2 (16.2)
17.3 (22.3)
16.1 (40.0)
17.3 (24.7)
15.3 (28.5)
18.2 (26.0)
23.1 (35.4)
22.1 (43.2)
(norm)
35.2 (13.6)
30.5 (36.2)
28.0 (69.2)
28.9 (45.1)
26.8 (44.9)
32.9 (30.0)
41.1 (35.0)
37.0 (59.1)
(h)
NC (NC)
2.53 (NC)
3.77 (136.4)
4.83 (45.7)
1.91 (129.8)
2.14 (114.9)
1.48 (71.3)
2.13 (119.4)
CL (L/h)
NC (NC)
106 (NC)
129 (61.8)
111 (12.1)
127 (40.5)
91.0 (18.1)
81.6 (39.9)
85.2 (41.0)
(L)
NC (NC)
72.8 (NC)
149 (365.2)
90.8 (7.1)
107 (195.5)
58.3 (29.5)
51.0 (45.1)
57.6 (61.8)
: number of patients studied. Median (min–max). (norm): normalised for dose. NC: not calculable. : 3. : 4. : 18. : 1; individual parameter presented.
