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
- 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
- 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.
- 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
- 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
- Treatment with drugs that are metabolized by the cytochrome P450 system (i.e warfarin
- 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
- 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
- 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.