NCT00560482

Efficacy Study of ABR-215050 to Treat Prostate Cancer

Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate ABR-215050 as a possible treatment for prostate cancer.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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)
DRUG	Placebo	Identical appearing gelatin capsules containing placebo

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-06-01
• Completion: 2015-08-01
• First posted: 2007-11-19
• Last updated: 2015-10-26

Locations

65 sites across 3 countries: United States, Canada, Sweden