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

NCT00106301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-11-18

No results posted yet for this study

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.

Conditions

  • Carcinoma, Renal Cell
  • Prostatic Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • William McCulloch, MB, FRCP · Gloucester Pharmaceuticals Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-01
Primary Completion
2006-09-01
Completion
2006-09-01

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00106301 on ClinicalTrials.gov