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An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients Clinical research trials and An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients. An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients clinical trial. Subjects frequently get the best healthcare possible for their An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients  An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients
An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Fujisawa Pharmaceutical , Fujisawa Healthcare, Inc.
Synopsis: 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.
Details: This is a Phase II, non-randomized, open-label, single arm, 2-stage trial.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry 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
Total Enrollment: 25
Location and Contact Information:
Additional Information:
Study ID Numbers: FJ-228-0002;
Study Start Date: April 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058643
Other Prostate Cancer Studies:
1. Gene-Environment Interaction in Prostate Cancer
2. Selenium and Vitamin E in Preventing Prostate Cancer
3. Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
4. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
5. Calcifidol Therapy in Men with Cancer
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An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients
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