Table 2 Dose escalation and treatment completion
Dose | N | Completed 12-week treatment | Reason for withdrawal |
---|---|---|---|
5 mg per day | 1 | Yes | |
10 mg per day | 1 | Yes | |
15 mg per day | 1 | Yes | |
30 mg per day | 1 | Yes | |
30 mg (10 mg t.d.s.) | 3 | No | Disease progression |
Yes | |||
Yes | |||
45 mg (15 mg t.d.s.) | 2 | Yes | |
Yes | |||
60 mg (20 mg t.d.s.) | 6 | No | Disease progression |
No | Disease progression | ||
No | Disease progression | ||
Yes | |||
Yes | |||
No | Adverse event (renal impairment) | ||
90 mg (30 mg t.d.s.) | 4 | No | DLT (grade 3 fatigue) |
Yes | |||
Yes | |||
No | DLT (grade 3 diarrhoea and muscle spasms) |