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Brief Title: Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel
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
Study ID: NCT00082134
Brief Summary: 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.
Detailed Description:
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Arizona Clinical Research Center, Tucson, Arizona, United States
Kansas City Cancer Centers, Lenexa, Kansas, United States
Kansas City Cancer Centers, Overland Park, Kansas, United States
Kansas City Cancer Centers- Central, Kansas City, Missouri, United States
Cancer Center of North Carolina- Cary, Cary, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
Sammons Cancer Center, Dallas, Texas, United States
Texas Cancer Center at Medical City, Dallas, Texas, United States
Joe Arrington Cancer Center, Lubbock, Texas, United States
North Texas Regional Cancer Center, Plano, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States