Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer
Primary Objective:

 -  To assess the tolerability at global doses

 Secondary Objectives:

 -  Safety

 -  Pharmacokinetics

 -  Efficacy
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after
 the last cabazitaxel administration.
Inclusion criteria :

 I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
 refractory to hormone therapy (received prior castration by orchiectomy and/or internal
 medicine, and documented progression of disease or relapse) who has previously been treated
 with docetaxel.

 I 02. Signed informed consent prior to beginning protocol specific procedures.

 I 03. Patients with PSA >20 ng/mL at screening.

 Exclusion criteria:

 E 01. Age <20 and >74

 E 02. ECOG performance status ≥2.

 E 03. Prior surgery ≤4 weeks of registration in the study.

 E 04. Active secondary cancer including prior malignancy from which the patient has been
 disease-free for ≤5 years (However, adequately treated superficial basal cell skin cancer
 before 4 weeks prior to registration can be eligible to the study)

 E 05. Inadequate organ function including:

 Neutrophils <2.0 x 109/L Platelets <100 x 109/L Hemoglobin <9.0 g/dL (transfusion
 prohibition within 14 days before registration) Creatinine >1.5 mg/dL. Total bilirubin >1.5
 times the upper normal limits of the institutional norms ALT/AST >1.5 times the upper
 normal limits of the institutional norms

 E 06. Previous treatment with <225 mg/m2 cumulative dose of Taxotere® (or docetaxel).

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.