Table 2. Exposure to BAY 43-9006 in patients with advanced, refractory solid tumours.
|
Starting dose of BAY 43-9006
|
||||||||
|---|---|---|---|---|---|---|---|---|
| 50 mg COMBa (n=7) | 100 mg b.i.d. (n=4) | 200 mg b.i.d. (n=3) | 300 mg b.i.d. (n=5) | 400 mg b.i.d. (n=10) | 600 mg b.i.d.b (n=12) | 800 mg b.i.d. (n=3) | Total (n=44) | |
| Median number of 28-day treatment cycles administered (range) | 2 (1–12) | 2.5 (2–4) | 2 (1–2) | 2 (1–6) | 3 (1–9) | 5 (2–14)b | 1 (1–10) | |
| No. of patients receiving more than three cycles (n (%)) | 1 (14) | 1 (25) | 0 (0) | 1 (20) | 3 (30) | 7 (58)b | 1 (33) | |
| Median duration of treatment, days (range)c | 42 (11–252) | 50 (42–84) | 42 (21–48) | 42 (21–104) | 48 (1–157) | 95 (11–261)b | 21 (13–175) | 42 (1–261) |
a
Combination of two different 50 mg presentations of study drug.
b
Nine of these patients were reduced to 400 mg b.i.d. due to toxicity.
c
Calculated by adding 21 days of study drug treatment for each completed 28-day cycle.