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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00082134 |
This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.
Condition | Intervention | Phase |
---|---|---|
Hormone-Refractory Prostate Cancer |
Drug: ILX651 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona Clinical Research Center | |
Tucson, Arizona, United States | |
United States, Kansas | |
Kansas City Cancer Centers | |
Overland Park, Kansas, United States | |
Kansas City Cancer Centers | |
Lenexa, Kansas, United States | |
United States, Missouri | |
Kansas City Cancer Centers- Central | |
Kansas City, Missouri, United States | |
United States, North Carolina | |
Cancer Center of North Carolina- Cary | |
Cary, North Carolina, United States | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States | |
United States, Texas | |
Joe Arrington Cancer Center | |
Lubbock, Texas, United States | |
Texas Cancer Center at Medical City | |
Dallas, Texas, United States | |
North Texas Regional Cancer Center | |
Plano, Texas, United States | |
Sammons Cancer Center | |
Dallas, Texas, United States | |
United States, Washington | |
Cancer Care Northwest | |
Spokane, Washington, United States, 99218 | |
Swedish Cancer Institute | |
Seattle, Washington, United States |
Study ID Numbers: | ILX651-241 |
Study First Received: | April 29, 2004 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00082134 |
Health Authority: | United States: Food and Drug Administration |
Prostate cancer Hormone-refractory prostate cancer HRPC Prostate |
Docetaxel PSA progression PSA progressed |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |