A Research Study for Patients With Metastatic Renal Cell Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Renal Cell, Neoplasm Metastasis

Intervention / Treatment
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* Drug: FK228 (romidepsin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Cell Carcinoma, Metastatic Cancer, Metastatic Renal Cell Carcinoma