Clinical Trial: An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients


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An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients

This study is currently recruiting patients.

Sponsored by:	Fujisawa Pharmaceutical Fujisawa Healthcare, Inc.
Information provided by:	Fujisawa Healthcare, Inc.

Purpose

The purpose of this study is to evaluate the activity of FK228 in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: FK228	Phase II

MedlinePlus related topics: Prostate Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Androgen Independent Metastatic Prostate Cancer Patients With a Rising PSA

Further Study Details:

Expected Total Enrollment: 25

Study start: April 2003

This is a Phase II, non-randomized, open-label, single arm, 2-stage trial.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male

Criteria

Inclusion Criteria

Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy
Have either measurable disease or bone metastasis
Rising PSA; minimum study entry PSA >= 5 ng/mL
For patients treated with anti-androgens, elevation of PSA must demonstrated after cessation of anti-androgen treatment

Exclusion Criteria

Prior treatment with chemotherapy
Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
QTc >= 500 msec
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Extensive radiotherapy involving >= 30% of bone marrow
Coexistent second malignancy or history of prior malignancy within previous 5 years

Location and Contact Information

Medical Information Dept. Respondent 800-727-7003 medical_information@fujisawa.com

Florida
Gainesville, Florida, United States; Recruiting

Illinois
Chicago, Illinois, United States; Recruiting

Washington
Seattle, Washington, 98109, United States; Recruiting

More Information

Click here for more information about the sponsor's affiliate: Fujisawa Healthcare, Inc.

Study ID Numbers: FJ-228-0002
Record last reviewed: April 2004
Record first received: April 8, 2003
ClinicalTrials.gov Identifier: NCT00058643
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10

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