Table 2.
Summary of Rova‐T plasma concentrations over time
| Visit | 0.3 mg/kg Rova‐T | Dose reduced 0.2 mg/kg Rova‐T | ||||||
|---|---|---|---|---|---|---|---|---|
| n | CV, % | Mean (SD) | Median (range) | n | CV, % | Mean (SD) | Median (range) | |
| Cycle 1 | ||||||||
| Day 1, 30‐minute postdose | 41 | 25.0 | 7.6 (1.9) | 7.7 (2.6–11.6) | – | – | – | – |
| Day 1, 4‐hour postdose | 43 | 18.7 | 7.1 (1.3) | 7.0 (4.7–10.9) | – | – | – | – |
| Day 2 | 44 | 17.8 | 5.5 (1.0) | 5.7 (3.6–7.7) | – | – | – | – |
| Day 3 | 44 | 20.4 | 4.3 (0.9) | 4.4 (2.7–5.9) | – | – | – | – |
| Day 4 | 43 | 21.1 | 3.6 (0.8) | 3.6 (2.2–5.1) | – | – | – | – |
| Day 8 | 45 | 29.9 | 2.2 (0.7) | 2.2 (1.0–4.5) | – | – | – | – |
| Day 15 | 42 | 28.1 | 1.5 (0.4) | 1.4 (0.7–2.3) | – | – | – | – |
| Cycle 2 | ||||||||
| Day 1 predose | 26 | 37.7 | 0.5 (0.2) | 0.5 (0.2–0.9) | 8 | 44.3 | 0.3 (0.1) | 0.3 (0.1–0.6) |
| Day 1, 30‐minute postdose | 24 | 21.4 | 7.9 (1.7) | 7.5 (4.7–10.8) | 8 | 20.8 | 5.2 (1.1) | 5.6 (3.4–6.2) |
| Day 1, 4‐hour postdose | 24 | 19.2 | 7.5 (1.4) | 7.2 (5.4–9.7) | 7 | 27.7 | 5.2 (1.4) | 5.6 (3.1–6.7) |
| Day 2 | 26 | 20.4 | 5.8 (1.2) | 5.7 (4.2–8.1) | 8 | 17.1 | 3.8 (0.7) | 3.8 (2.5–4.8) |
| Day 3 | 26 | 21.0 | 4.7 (1.0) | 4.8 (3.3–6.6) | 8 | 21.4 | 3.0 (0.6) | 3.1 (2.1–3.9) |
| Day 4 | 26 | 22.3 | 3.9 (0.9) | 4.0 (2.9–5.9) | 8 | 21.4 | 2.5 (0.5) | 2.5 (1.6–3.4) |
| Day 8 | 26 | 23.7 | 2.6 (0.6) | 2.7 (1.5–4.0) | 8 | 17.2 | 1.8 (0.3) | 1.8 (1.2–2.1) |
| Day 15 | 22 | 27.6 | 1.8 (0.5) | 1.7 (1.1–3.3) | 6 | 23.0 | 1.2 (0.3) | 1.3 (0.7–1.5) |
CV, coefficient of variation; Rova‐T, rovalpituzumab tesirine.