Efficacy Study of ABR-215050 to Treat Prostate Cancer
Recruitment status was Active, not recruiting
To investigate ABR-215050 as a possible treatment for prostate cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer|
- Disease progression, defined as onset of tumor-related cancer pain, measurable disease progression, bone metastases or other non-target lesions, need for radiotherapy or surgery for pathological fracture or spinal cord compression [ Time Frame: 3 months, 6 months; continuation phase every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Drug: ABR-215050, tasquinimod
Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
|Placebo Comparator: B||
Identical appearing gelatin capsules containing placebo
For asymptomatic patients with Castrate-Resistant Prostate Cancer (CRPC), a "window of opportunity" is present. During this "window of opportunity" an intervention with little or no toxicity and the potential for extending the "symptom-free" period would be of great value to keep metastatic patients in an asymptomatic stage and thus delay the introduction of chemotherapy. The purpose of this study is to evaluate the safety and efficacy of ABR-215050 as an interventional agent for this role.
Overall survival for patients participating in study 07TASQ08 will be evaluated retrospectively using a separate study protocol 11TASQ11.
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|Study Director:||Goran Forsberg, Assoc. Prof.||Active Biotech AB|
|Principal Investigator:||Roberto Pili, MD||Roswell Park Cancer Institute, Buffalo, New York|