Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

The study consists of:

• a screening phase (maximum length of 7-day).
• a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent.
• a 30-day follow-up visit after the last dose of study medication.

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
• Patient is ≥ 18 years and ≤ 75 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin < Upper Normal Limit (ULN); Serum Glutamate Oxaloacetate Transaminase (Aspartate Aminotransferase)/SGOT (AST) < 1.5xULN; Serum Glutamate Pyruvate Transaminase (Alanine Aminotransferase)/SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN. In case of creatinine > 1.0 x ULN and < or = 1.5 x ULN, calculated creatinine clearance according to CKD-EPI formula should be > or = 60 ml/min.
• Written informed consent must be obtained prior to any study related procedures

Exclusion criteria

• Prior radiotherapy to ≥ 40% of bone marrow
• Previous treatment with cabazitaxel (Jevtana®)
• 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
• 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 diabetes mellitus)
• Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2 weeks wash-out period is necessary for patients who are already on these treatments). Participation in any other 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.