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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405210
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : May 23, 2011
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Disease Prostate Cancer Drug: sorafenib (200 or 400mg bid) and taxotere iv Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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
    Other Name: Nexavar

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel* [ Time Frame: after the first 24 patients ]
  2. Toxicity and safety [ Time Frame: at end of study ]
  3. Response rate in patients with measurable disease [ Time Frame: at end of study ]
  4. PSA response rate [ Time Frame: at end of study ]
  5. PSA response duration [ Time Frame: at end of study ]
  6. Time to PSA progression (=time between treatment start and PSA progression) [ Time Frame: at end of study ]
  7. 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 ]
  8. Event progression-free survival [ Time Frame: at end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent prior to beginning protocol specific procedures.
  • 18 years
  • Radiologically proven presence of metastases
  • Histologically/cytologically proven prostate adenocarcinoma.
  • Biochemically evaluable disease
  • Patients must have received prior hormonal therapy as defined below:

    • Castration by orchiectomy and/or LHRH agonists with or without
    • Antiandrogens
    • Other hormonal agents (e.g., ketoconazole, ...)
  • The testosterone level should be < 50 ng/dl (10) documented disease progression defined by PSA increase. Patients must have a value of at least 5 ng/ml in addition to increasing PSA to be eligible.
  • Life expectancy > 3 months
  • ECOG performance status 0-2.
  • Normal cardiac function.

Exclusion Criteria:

  • Prior chemotherapy except estramustine phosphate.
  • Prior isotope therapy (e.g., strontium, samarium).
  • Prior radiotherapy to >25% of bone marrow
  • Prior therapy with anti-VEGF therapy
  • Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
  • History or presence of central nervous system (CNS) disease (i.e. primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
  • Symptomatic peripheral neuropathy
  • Other serious illness or medical condition the use of corticosteroids.
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BAY 9006.
  • Major surgery with 4 weeks of study entry
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
  • Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry
  • Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped.
  • Treatment with drugs that are metabolized by the cytochrome P450 system (i.e warfarin sodium,…)
  • Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped.
  • Biphosphonates could not be initiated after inclusion into the protocol. At inclusion, patients receiving biphosphonates with a PSA progression could continue biphosphonates.
  • Patients with reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial.
  • Inadequate recovery from previous surgery, radiation, chemo-, biologic or immunotherapy
  • Patients who have known hypersensitivity to the study medication
  • Substance abuse, medical social, psychological conditions that may interfere with the subject's participation in the study or evaluation of study results
  • Patients unable to sallow oral medications.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00405210

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St Pierre
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
Sainte Elisabeth
Namur, Belgium, 5000
Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Study Director: Jean-Pascal H Machiels, Prof Cliniques Universitaires St Luc -UCL

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Responsible Party: Cliniques universitaires Saint-Luc-Université Catholique de Louvain, Prof. J-P Machiels Identifier: NCT00405210    
Other Study ID Numbers: UCL-ONCO 06-003
BAY 43-9006/12180
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
metastatic prostatic cancer
naïve patient
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators