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news.Spectrum Pharmaceuticals has said that the Therapeutic Product Directorate of Health Canada has approved company's clinical trial application to conduct Phase III clinical trials for EOquin for non-invasive bladder cancer.
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The EOquin registration plan calls for two double blind, placebo-controlled, randomized Phase III clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint is a statistically significant difference (p<0.05) in the rate of tumor recurrence between the two treatment groups by year two. The first Phase III study is currently expected to complete enrollment by end of 2008, and the second Phase III trial to be fully enrolled by mid 2009.