Table 3.

Dose Escalation

Dose level	BPU dose (mg)	No. of patients	No. of cyclesa	No. of DLT
1	5	1	2	0
2	10	1	2	0
3	20b	1	15	0
4	40	1	2	0
5	80	1	2	0
6	160	1	2	0
7	320c	6	14	2
8	150d	7e	15	0

^aEach cycle consisted of four weekly doses of oral BPU (one month)

^bThis patient received three cycles (cycles 6-8) of drug administration at 40 mg, and was subsequently returned to 20 mg due to grade 3 syncope. This was the only subject who was dose-escalated.

^cDose level expanded due to decline in apparent clearance

^dFor this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.

^eOne patient not evaluable for toxicity due to early progression