Metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen MedDRA version: 14.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jevtana
Product Name: CABAZITAXEL
Product Code: XRP6258
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Sponsors
sanofi-aventis groupe
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Metastatic Hormone Refractory Prostate Cancer previously treated with a docetaxel-containing regimen 3. Disease Progression during or after docetaxel-containing regimen for mHRPC 4. Surgical or medical castration 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2 6. Life-expectancy =3 months 7. Adequate bone marrow, liver, and renal function: Neutrophils> 1500 /mm3; Hemoglobin > 10 g/dL; Platelets > 100 x109/L; Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to = 40% of bone marrow 2. Prior radionuclide therapy with samarium-153 or P-32 within 8 weeks prior to enrollment or with strontium-89 or radium-223 within 12 weeks prior to enrollment 3. Prior surgery, radiation or chemotherapy within 4 weeks prior to enrolment (this 4-week wash-out period is aimed to allow the patient to recover from any side effects of previous therapy) 4. Active grade =2 peripheral neuropathy 5. Active grade =2 stomatitis 6. Active infection requiring systemic antibiotic or anti-fungal medication 7. 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) 8. Known brain or leptomeningeal involvement 9. History of severe hypersensitivity reaction (=grade 3) to docetaxel 10. History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs 11. History of severe hypersensitivity reaction (=grade 3) or intolerance to prednisone or prednisolone 12. Uncontrolled severe illness or medical condition (including uncontrolled cardiac arrhythmias, angina pectoris, hypertension or uncontrolled diabetes mellitus). History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed. 13. Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B) 14. Treatment with any investigational drug within 4 weeks prior to enrolment 15. Patient with reproductive potential not implementing accepted and effective method of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Main Objective: to allow patients similar to those evaluated in the TROPIC trial, and Investigators access to cabazitaxel for the management of metastatic Hormone Refractory Prostate Cancer (mHRPC) in patients who have progressed during or after docetaxel, and to document the overall safety of cabazitaxel in these patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Finland, Hungary, India, Ireland, Italy, Malaysia, Mexico, Philippines, Portugal, Singapore, Slovakia, Spain, Sweden, Taiwan, United Kingdom
Contacts
Public ContactMedical Information
sanofi-aventis groupe
Outcome results
None listed