A Research Study for Patients With Metastatic Renal Cell Carcinoma

October 16, 2019 updated by: Celgene

An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy

The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation:

  • Age ≥ 18 years;
  • Histologically confirmed Renal Cell Carcinoma (RCC);
  • Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
  • Failure of prior cytokine therapy;
  • Documented progressive disease;

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

  • Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
  • History of serious ventricular arrhythmia
  • Corrected QT interval (QTc) ≥ 500 msec
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
  • Previous extensive radiotherapy involving ≥ 30% of bone marrow
  • Coexistent second malignancy or history of prior malignancy within previous 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FK228 (romidepsin)
13 mg/m2 of romidepsin
Drug: FK228 (romidepsin)
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
  • romidepsin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
Time Frame: Up to 6 months
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of disease control, Complete Response, Partial Response, or Stable Disease
Time Frame: Up to 6 months
Up to 6 months
Time to objective disease progression.
Time Frame: Up to 6 months
Up to 6 months
Number of Participants with Adverse Events
Time Frame: Up to 6 months
Up to 6 months
Change from screening assessment to the final study visit in Karnofsky performance status.
Time Frame: Up to 6 months
Up to 6 months
Steady state plasma concentrations
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: William McCulloch, MB, FRCP, Gloucester Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2003

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 28, 2005

First Submitted That Met QC Criteria

March 28, 2005

First Posted (Estimate)

March 29, 2005

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJ-228-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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