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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study with and without Enzastaurin in Combination with Docetaxel and Prednisone, Followed by Enzastaurin Maintenance as First-Line Treatment in ...

Update Il y a 5 ans
Reference: EUCTR2008-004451-30

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study with and without Enzastaurin in Combination with Docetaxel and Prednisone, Followed by Enzastaurin Maintenance as First-Line Treatment in Hormone Refractory Metastatic Prostate Cancer Patients

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Extract

The primary objective of this study is to compare the objective response rate of enzastaurin given in combination with docetaxel and prednisone followed by enzastaurin maintenance therapy in patients with HRPC during first-line therapy versus placebo plus docetaxel and prednisone followed by placebo as maintenance. An objective response rate is assessed via objective lesion response and a 50% decline from baseline in PSA.

Inclusion criteria

  • Androgen-independent metastatic prostate cancer

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