Trial | NCT00106613  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    romidepsin ...

  • Study Participants

    30
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 Started
May 01
2003
Primary Completion
Aug 01
2004
Study Completion
Aug 01
2004
Last Update
Oct 18
2019

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

FK228 (romidepsin) Experimental

13 mg/m2 of romidepsin

Criteria 

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
No Results Posted