Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer
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|ClinicalTrials.gov Identifier: NCT00405210|
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : May 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Disease Prostate Cancer||Drug: sorafenib (200 or 400mg bid) and taxotere iv||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||December 2009|
- 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 cyclesOther Name: Nexavar
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|