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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Prostatic Neoplasms

Thank you

Trial Information

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Time Frame:

Up to 6 months

Safety Issue:

Yes

Principal Investigator

William McCulloch, MB, FRCP

Investigator Role:

Study Director

Investigator Affiliation:

Gloucester Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

FJ-228-0007

NCT ID:

NCT00106301

Start Date:

April 2004

Completion Date:

September 2006

Related Keywords:

  • Carcinoma, Renal Cell
  • Prostatic Neoplasms
  • FK228
  • Hormone Refractory Prostate Cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Prostatic Neoplasms

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010
Seattle Cancer Care AllianceSeattle, Washington  98109
University of FloridaGainesville, Florida  32610-0277
University of ChicagoChicago, Illinois  60637