Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer
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.
|Primary Disease Prostate Cancer||Drug: sorafenib (200 or 400mg bid) and taxotere iv||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the recommended dose of BAY 43-9006 (SORAFENIB) in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone refractory prostate cancer. [ Time Frame: after the first 24 patients ]
- Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel* [ Time Frame: after the first 24 patients ]
- Toxicity and safety [ Time Frame: at end of study ]
- Response rate in patients with measurable disease [ Time Frame: at end of study ]
- PSA response rate [ Time Frame: at end of study ]
- PSA response duration [ Time Frame: at end of study ]
- Time to PSA progression (=time between treatment start and PSA progression) [ Time Frame: at end of study ]
- Time to PSA progression after the last dose of docetaxel in patients with no progression after stopping docetaxel (= time between the last dose of docetaxel and PSA progression) [ Time Frame: at end of study ]
- Event progression-free survival [ Time Frame: at end of study ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Drug: sorafenib (200 or 400mg bid) and taxotere iv
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405210
|Ottignies, Brabant Wallon, Belgium, 1340|
|Cliniques Universitaires St Luc|
|Brussels, Brussels Capital, Belgium, 1200|
|Notre Dame et Reine Fabiola|
|Charleroi, Hainaut, Belgium, 6000|
|Clinique Universiataire de Mont Godinne|
|Yvoir, Namur, Belgium, 5030|
|Namur, Belgium, 5000|
|Hôpital Européen Georges Pompidou|
|Paris, France, 75015|
|Study Director:||Jean-Pascal H Machiels, Prof||Cliniques Universitaires St Luc -UCL|