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

Conditions: Metastatic hormone refractory prostate cancer previously treated with a docetaxel-containing regimen
MedDRA version: 16.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2010-021128-92-DK

Lead Sponsor: sanofi aventis groupe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 1000

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 < 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

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 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. Treatment with any investigational drug within 4 weeks prior to enrolment
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
Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable;Secondary Objective: 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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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