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

Inclusion criteria:

• Metastatic Hormone Refractory Prostate Cancer (mHRPC) previously treated with a docetaxel-containing regimen
• Disease Progression during or after docetaxel-containing regimen for mHRPC
• Surgical or medical castration
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
• Life-expectancy ≥3 months
• Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded.

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.