Phase III clinical trial of tasquinimod in mCRPC

The “New” Prostate Cancer InfoLink has been definitively advised by Active Biotech AB that the randomized, double-blind, placebo-controlled, Phase III clinical trial of tasquinimod has been enrolling patients with metastatic, castration-resistant prostate cancer (mCRPC) since some time in the first 3 months of this year.

Yesterday we had seen a report suggesting that this trial had been delayed until 2012. We are pleased to have learned that this is not the case.

The current trial is enrolling 1,200 men with asymptomatic or mildly symptomatic, but clinically evident, metastatic disease who have progressed with a rising PSA after treatment that maintained their serum testosterone level at or below castrate levels (i.e., ≤ 50 ng/dl or 1.7 nmol/l). Of the 1,200 patients being enrolled into this trial, 800 will be randomized to treatment with tasquinimod at a dose of 0.25, 0.5, or 1 mg/day; the other 400 patients will be randomized to treatment with a placebo. Tasquinimod is an oral drug taken just once a day.

There is a long list of exclusion criteria for this trial, particularly exclusion criteria that are designed to make sure patients have not recently received any form of chemotherapy or biologic therapy. Acceptable forms of continuing therapy include LHRH agonists or antagonists (e.g., leuprolide acetate or degarelix) and drugs to prevent bone loss and deterioration (e.g., zoledronate or denosumab). However, patients can not be taking antiandrogens (e.g., bicalutamide) or other forms of hormonal therapy (e.g., ketoconazole).

The trial is currently recruiting patients at 16 centers in the US, three on Belgium, and one in Canada. We assume that the number of centers recruiting patients will be increased over the next few months. The projected timeframe for this trial is as much as 5 years before we will know whether tasquinimod can delay time to objective disease progression compared to the placebo in chemotherapy-naïve patients with mCRPC. In other words, it will likely be 2016 before the results of this trial are available.

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