Table 2.
Dose level (mg/m2/day) | n | Cmax (mcg/ml) | Tmax (h) | AUC0–24 h (mcg h/ml) | AUC0−∞ (mcg h/ml) | T1/2 (h) | CL/F (ml/min/m2) |
---|---|---|---|---|---|---|---|
75 | 3 | 8.1 (6.3–9.7) | 3.0 (2.0–3.0) | 40 (34–72) | 44 (36–76) | 6.0 (5.8–7.0) | 29 (18–33) |
100 | 8 | 11 (5.6–15) | 2.0 (0.9–4.0) | 55 (35–71) | 57 (41–92) | 6.0 (2.4–25) | 29 (16–39) |
100a | 2b | 7.2, 11 | 1.0, 3.0 | 48, 53 | 49, 58 | 5.0, 6.2 | 28, 30 |
130 | 6 | 9.6 (8.6–16) | 2.0 (1.1–3.1) | 58 (42–93) | 64 (43–96) | 4.8 (3.5–19) | 33 (22–39) |
130a | 3 | 9.6 (7.8–12) | 3.0 (1.0–6.0) | 68 (44–74) | 70 (45–78) | 4.8 (3.4–5.1) | 30 (26–55) |
165 | 9 | 11 (8.1–21) | 3.0 (1.0–5.0) | 94 (50–119) | 96 (53–122) | 5.0 (3.8–11) | 29 (23–47) |
200 | 6 | 17 (8.5–29) | 2.5 (1.2–5.7) | 83 (56–118) | 87 (64–123) | 5.4 (2.3–8.4) | 37 (25–43) |
200a | 23 | 17 (4.6–34) | 3.0 (1.0–6.0) | 90 (28–156) | 95 (29–183) | 4.8 (2.2–9.0) | 34 (17–122) |
250 | 2b | 19, 28 | 1.9, 2.1 | 106,134 | 114, 144 | 2.5, 6.2 | 30, 37 |
Monitored with the limited sampling schedule
Data presented in this row represents the values for the 2 patients studied at this dose level
Cmax peak plasma concentration; Tmax time that the peak concentration in plasma was achieved; AUC area under the plasma concentration–time curve; T1/2 half-life in plasma; CL/F apparent clearance