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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00106301

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

0.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell Prostatic Neoplasms	Drug: FK228 (romidepsin)	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FK228 (romidepsin) romidepsin	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. Other Names: romidepsin

Arm

Intervention/Treatment

Experimental: FK228 (romidepsin)

romidepsin

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.

Other Names:

romidepsin

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [Up to 6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010-3000
2	University of Florida	Gainesville	Florida	United States	32610
3	University of Chicago	Chicago	Illinois	United States	60637-1470
4	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
5	Royal Marsden Hospital	Sutton		United Kingdom	SM2 5PT