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

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell; Prostatic Neoplasms
• Interventions: Drug: FK228 (romidepsin)

• Registration Number: NCT00106301
• Lead Sponsor: Celgene

Brief 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.

Study Timeline

• Study Start: 2004-04-01
• Study First Submitted: 2005-03-22
• Study First Submitted QC: 2005-03-22
• Study First Posted: 2005-03-23
• Primary Completion: 2006-09-01
• Study Completion: 2006-09-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;
• Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;
• Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial.

Exclusion Criteria

• Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FK228 (romidepsin)	FK228 (romidepsin)	romidepsin

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the time to objective disease progression.	Up to 6 months
To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment	Up to 6 months

Trial Locations

Locations (5)

University of Florida; 🇺🇸 Gainesville, Florida, United States

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

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

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

Royal Marsden Hospital; 🇬🇧 Sutton, United Kingdom