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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 ...

Mise à jour : Il y a 4 ans
Référence : 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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Extrait

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.

Critère d'inclusion

  • Androgen-independent metastatic prostate cancer

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