A Research Study for Patients With Metastatic Renal Cell Carcinoma

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell; Neoplasm Metastasis
• Interventions: Drug: FK228 (romidepsin)

• Registration Number: NCT00106613
• Lead Sponsor: Celgene

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05-01
• Primary Completion: 2004-08-01
• Study Completion: 2004-08-01
• Study First Submitted: 2005-03-28
• Study First Submitted QC: 2005-03-28
• Study First Posted: 2005-03-29
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FK228 (romidepsin)	FK228 (romidepsin)	13 mg/m2 of romidepsin

Primary Outcome Measures

Name	Time	Method
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).	Up to 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States