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

Status:	Completed
Conditions:	Prostate Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	April 2004
End Date:	September 2006

A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228

The purpose of this study is to evaluate the safety and tolerability of extended treatment
with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate
cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228
clinical trials.

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

We found this trial at

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261