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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Page 1 of 2 (5 locations)

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