Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Inclusion Criteria:

- Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228
clinical trial;

- Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle
6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;

- Patient has demonstrated stable disease, partial response or complete response as
best overall response in their prior Fujisawa-sponsored FK228 clinical trial.

Exclusion Criteria:

- Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial
and then received alternative anti-neoplastic therapy