Table 2. Pharmacokinetics parameters of DT01 administered locally.
| Route |
IT+PT |
PT | ||||
|---|---|---|---|---|---|---|
| Dose | 16 mg | 32 mg | 48 mg | 64 mg | 96 mg | 96 mg |
| No. of patients | 3 | 3 | 3 | 3 | 5 | 6 |
| Cmax, μg ml−1 | 0.23 (0.10) | 0.60 (0.77) | 1.88 (0.72) | 1.04 (0.91) | 0.69 (0.44) | 0.32 (0.08) |
| AUC0–24, μg.h ml−1 | 0.92 (0.30) | 2.04 (2.15) | 6.67 (1.00) | 3.44 (3.33) | 4.72 (3.15) | 2.64 (0.90) |
| Half-life, h | 3.15 (0.27) | 3.69 (3.06) | 2.37 (0.26) | 3.53 (2.42) | 4.91 (2.01) | 4.57 (1.42) |
| Tmax, h | 1.0 (1.0–2.5) | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) | 2.75 (1.0–4.5) | 3.5 (1.0–9.0) |
Abbreviations: AUC0–24=area under the curve of plasma concentration vs time from time zero to 24 h; Cmax=maximum plasma concentration; IT=intratumoural; PT=peritumoural; Tmax=time to reach Cmax.
Means (s.d.) are given for relative dose, Cmax, AUC0–24 and half-life; medians (range) are given for Tmax.