Prostate Cancer Clinical Trial
Official title:
Open-label, Multicenter,PhaseI Trial in Order To Determine the Safety and Pharmacokinetics of BAY43-9006 in Combination With Docetaxel as First-line Treatment in Metastatic Hormone Refractory Prostate Cancer Patients
The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated
to taxotere for first-line treatment of patient with prostatic cancer.
BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is
orally available and has a favorable safety profile in patients with advanced solid tumors.
This, together with the antitumor activity observed after treatment with BAY 43-9006
(SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer.
The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a
continuous dosing schedule.
This study propose to treat patients with metastatic and hormone-refractory prostatic cancer
in first intention. There is no limits of age from 18 years old. A new inhibitor of
angiogenesis (Sorafenib) is associated to the standard treatment in this type of pathology.
Patients have to demonstrate radiologically a disease progression and also a progression
based on increase of psa level.
The main objective is to Determine the recommended dose of BAY 43-9006 in combination with
docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients
with metastatic hormone-refractory prostate cancer.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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