E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HORMONE REFRACTORY PROSTATE CANCER |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Programma di accesso allargato |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 106 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Lo studio si concludera` quando cabazitaxel sara` disponibile in commercio, i pazienti arruolati saranno trattati fino a progressione di malattia, decesso, tossicita` inaccettabile, decisione dello sperimentatore o fino ad un massimo di 10 cicli. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |