MULTICENTRE, SINGLE-ARM, OPEN LABEL CLINICAL TRIAL INTENDED TO PROVIDE EARLY ACCESS TO CABAZITAXEL IN PATIENTS WITH METASTATIC HORMONE REFRACTORY PROSTATE CANCER PREVIOUSLY TREATED WITH A DOCETAXEL-CONTAINING REGIMEN AND TO DOCUMENT SAFETY OF CABAZITAXEL IN THESE PATIENTS - ND
- Conditions
- HORMONE REFRACTORY PROSTATE CANCERMedDRA version: 9.1Level: PTClassification code 10036909
- Registration Number
- EUCTR2010-021128-92-IT
- Lead Sponsor
- sanofi-aventis Groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1000
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 < ULN; SGOT (AST) < 1.5xULN; SGPT (ALT) < 1.5xULN; Creatinine < 1.5xULN; 8. Signed written informed consent obtained prior to enrolment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Prior radiotherapy to >= 40% of bone marrow; 2. Prior radionuclide therapy (samarium-153, strontium-89, P-2); 3. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment; 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 diabetes mellitus); 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. Participation in a clinical trial with any investigational drug; 15. Patient with reproductive potential not implementing accepted and effective method of contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is 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 and to document the overall safety of cabazitaxel in these patients.;Secondary Objective: N.A.;Primary end point(s): n.a.
- Secondary Outcome Measures
Name Time Method