Table 2. Dose level evaluated and DLT encountered.

Dose level	Dose	Schedule	Total no. of cycles	No. of patients with DLT/total no. of patients treated	DLT
1	10	3 days every 2 weeks	6	0/3
2	10	5 days every 2 weeks	16	1/6a
3	20	5 days every 2 weeks	20	1/6	Grade 3 myositis
4	30	5 days every 2 weeks	19	0/4
5	50	5 days every 2 weeks	6	0/4
6	70	5 days every 2 weeks	5	0/3
7	90	5 days every 2 weeks	3	1/2b	Grade 3 fatigue Grade 3 vomiting
6	70	5 days every 2 weeks	4	3/3	Grade 4 platelets Grade 3 fatigue
5.5	60	5 days every 2 weeks	17	1/7c	Grade 3 ALTd

Abbreviations: DLT=dose-limiting toxicity; ALT=alanine transaminase.

^aGrade 3 bilirubin subsequently declared not drug related.

^bNeither patient completed a full cycle.

^cOne patient had intolerable G2 nausea vomiting resulting in failure to receive further dose. Although this is not DLT per se according to protocol definition, we have classified this event as a DLT due to the inability to resume treatment.

^dOne patient did not complete cycle 1 because of ALT rise, however, it was not clear if this was entirely related to drug since patient had elevated transaminases with prior treatment.