Early Access to Cabazitaxel in Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen

Exclusion Criteria

• •Prior radiotherapy to ≥ 40% of bone marrow
• •Prior radionuclide therapy (samarium-153, strontium-89, P-32…)
• •Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment
• •Active grade ≥2 peripheral neuropathy
• •Active grade ≥2 stomatitis
• •Active infection requiring systemic antibiotic or anti-fungal medication
• •Active cancer (other than mHRPC) including prior malignancy from which the patient has been disease-free for ≤5 years (except superficial basal cell skin cancer)
• •Known brain or leptomeningeal involvement
• •History of severe hypersensitivity reaction (≥grade 3) to docetaxel
• •History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs
• •History of severe hypersensitivity reaction (≥grade 3) or intolerance to prednisone or prednisolone
• •Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhythmias, angina pectoris, hypertension or diabetes mellitus). History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed.
• •Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5
• •Participation in a clinical trial with any investigational drug
• •Patient with reproductive potential not implementing accepted and effective method of contraception
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.