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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00106301

First received: March 22, 2005

Last updated: March 30, 2016

Last verified: March 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2005

Last Updated Date

March 30, 2016

Start Date ^ICMJE

April 2004

Primary Completion Date

September 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participants with adverse events [ Time Frame: Up to 6 months ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00106301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment [ Time Frame: Up to 6 months ]
To evaluate the time to objective disease progression. [ Time Frame: Up to 6 months ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Renal Cell
Prostatic Neoplasms

Intervention ^ICMJE

Drug: FK228 (romidepsin)

Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Other Name: romidepsin

Study Arms

Experimental: FK228 (romidepsin)

romidepsin

Intervention: Drug: FK228 (romidepsin)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

September 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00106301

Other Study ID Numbers ^ICMJE

FJ-228-0007

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Celgene Corporation

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

William McCulloch, MB, FRCP

Gloucester Pharmaceuticals Inc.

PRS Account

Celgene Corporation

Verification Date

March 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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