Prostate Cancer
Conditions
Brief summary
Primary Objective: * To assess the tolerability at global doses Secondary Objectives: * Safety * Pharmacokinetics * Efficacy
Detailed description
The duration of screening within 28 days, treatment 3 weeks/cycle and follow-up 30 days after the last cabazitaxel administration.
Interventions
Pharmaceutical form:solution Route of administration: intravenous
DRUGprednisolone
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 73 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of maximum tolerated dose | up to 18 months |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with treatment emergent adverse events | up to 18 months |
| Pharmakokinetic parameters of Cabazitaxel | up to 18 months |
| Prostate Specific Antigen (PSA) Response | up to 18 months |
Countries
Japan
Outcome results
None listed