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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 isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients conditions. Clinical Trials Search.org is a site dedicated 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies 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 healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again 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 typically recieve the finest healthcare available for their An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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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. A Phase III, Randomized Study of Atrasentan in Men with Metastatic, Hormone-Refractory Prostate Cancer
2. Calcifidol Therapy in Men with Cancer
3. Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
4. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
5. Safety and Efficacy Study of Omnitarg (Pertuzumab) to Treat Castration-Resistant Prostate Cancer
Related Studies:
Other Prostate Cancer Clinical Trials
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An Exploratory Trial Evaluating the Activity and Tolerability of FK228 in Metastatic Prostate Cancer Patients
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