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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
...and 2 more locations
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