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

• Register: EUCTR
• Last refreshed on: 19 September 2016
• Main ID: EUCTR2010-021128-92-IE
• Date of registration: 21/01/2011
• 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
• 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
• Date of first enrolment: 05/04/2011
• 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: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes

Countries of recruitment

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

• Name: Medical Information
• Affiliation: sanofi-aventis groupe

• Name: Medical Information
• Affiliation: sanofi-aventis groupe

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. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance < 60 mL/min should be excluded (see Appendix C for formula).
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 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



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

Health Condition(s) or Problem(s) studied

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)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Jevtana
Product Name: CABAZITAXEL
Product Code: XRP6258
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: cabazitaxel
CAS Number: 183133-96-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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 Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

CABAZ_C_05331

NCT01254279

2010-021128-92-GB