Clinical trial NCT00106301: Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
Official title: A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Prostatic Neoplasms
Keywords: FK228
Hormone Refractory Prostate Cancer
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2005-03-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 6 months
Secondary outcomes:
measure: To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
timeFrame: Up to 6 months
measure: To evaluate the time to objective disease progression.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Gloucester Pharmaceuticals Inc.
name: William McCulloch, MB, FRCP
role: STUDY_DIRECTOR
References:
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