A Research Study for Patients With Metastatic Renal Cell Carcinoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00106613

Enrollment

Registered

2005-03-29

Start date

2003-05-01

Completion date

2004-08-01

Last updated

2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell, Neoplasm Metastasis

Keywords

Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma

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.

Interventions

DRUGFK228 (romidepsin)

Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026