According to a December 10 media release issued by Active Biotech and Ipsen, the pivotal Phase III trial of tasquinimod versus a placebo in the treatment of men with asymptomatic to mildly symptomatic, metastatic, castration-resistant prostate cancer (mCRPC) is also now fully enrolled.
The trial is a global, randomized, double-blind, placebo-controlled clinical study of tasquinimod. More than 1,200 patients with asymptomatic or mildly symptomatic mCRPC have been enrolled at 250 different centers around the world and randomized to treatment with tasquimimod (at a dose of up to 1 mg/day) or a placebo. This trial used a 2:1 randomization process, meaning that about 800 patients were randomized to treatment with tasquinimod and 400 to treatment with a placebo. The study is designed to demonstrate the efficacy and safety of tasquinimod in men with mCRPC, using radiological progression-free survival (rPFS) as the primary endpoint and overall survival (OS) as a secondary endpoint.
The estimated study completion date for this trial is not until January 2016. However, The ?New? Prostate Cancer InfoLink would expect that we might see data on the primary rPFS endpoint significantly earlier than that date (e.g., by late in 2013 or some time in 2014) if there is a significant difference between the effects of tasquinimod and a placebo (which there ought to be based on the Phase II trial data).
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Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment Tagged: | castration-resistant, mCRPC, metastatic, tasquinimod
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