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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


Phase 1
18 Years
N/A
Not Enrolling
Male
Primary Disease, Prostate Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

after the first 24 patients

Safety Issue:

Yes

Principal Investigator

Jean-Pascal H Machiels, Prof

Investigator Role:

Study Director

Investigator Affiliation:

Cliniques Universitaires St Luc -UCL

Authority:

Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

UCL-ONCO 06-003

NCT ID:

NCT00405210

Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Primary Disease
  • Prostate Cancer
  • hormone-resistant
  • metastatic prostatic cancer
  • pharmacokinetics
  • naïve patient
  • Prostatic Neoplasms

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