Status:
COMPLETED
Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
Lead Sponsor:
Celgene
Conditions:
Carcinoma, Renal Cell
Prostatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
This is a Phase II, non-randomized, open-label, single arm, continuation trial.
Eligibility Criteria
Inclusion
- 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
- Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00106301
Start Date
April 1 2004
End Date
September 1 2006
Last Update
November 18 2019
Active Locations (5)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
University of Florida
Gainesville, Florida, United States, 32610
3
University of Chicago
Chicago, Illinois, United States, 60637-1470
4
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109