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A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus in Men With Asymptomatic, Metastatic Castrate-Resist...

Update Il y a 4 ans
Reference: EUCTR2008-000422-39

A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus in Men With Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer

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Extract

To determine the efficacy of the combination of ridaforolimus and bicalutamide compared to placebo and bicalutamide by PSA decline within 12 weeks, a surrogate measurement of overall survival efficacy in prostate cancer therapy trials. To determine the safety and tolerability of ridaforolimus when combined with bicalutamide.

Inclusion criteria

  • metastatic prostate cancer

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