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

• Register: EUCTR
• Last refreshed on: 30 June 2014
• Main ID: EUCTR2010-021128-92-IT
• Date of registration: 19/11/2010
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Groupe
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 02/12/2010
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021128-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Czech Republic, Denmark, Finland, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom

Key inclusion & exclusion 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 < 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 (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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

HORMONE REFRACTORY PROSTATE CANCER
MedDRA version: 9.1 Level: PT Classification code 10036909

Intervention(s)

Trade Name: Jevtana
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: cabazitaxel
Current Sponsor code: XRP6258
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: DELTACORTENE
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: N.A.

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.

Primary end point(s): n.a.

Secondary ID(s)

2010-021128-92-GB

CABAZ_C_05331