NCT00405210

Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Disease
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	sorafenib (200 or 400mg bid) and taxotere iv	200 mg BID, day 3-19 cycle 1, day 2-19 other cycles 200 mg BID, day 3-21 Cycle 1, day 1-21 other cycles 400 mg BID, day 3-19 cycle 1, day 2-19 other cycles 400 mg BID, day 3-21 cycle 1, day 1-21 other cycles

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-08-01
• Completion: 2009-12-01
• First posted: 2006-11-29
• Last updated: 2011-05-23

Locations

6 sites across 2 countries: Belgium, France