NCT00106301

Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.

Detailed description

This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Conditions

• Carcinoma, Renal Cell
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	FK228 (romidepsin)	Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-03-23
• Last updated: 2019-11-18

Locations

5 sites across 2 countries: United States, United Kingdom