E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced or metastatic hormone-refractory prostate cancer |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029096 |
E.1.2 | Term | Neoplasm prostate |
|
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 |
To evaluate the biochemical responses as determined by PSA value. |
|
E.2.2 | Secondary objectives of the trial |
Determine the treatment activity in terms of objective responses. Determine the toxicity profile of Chetoconazolo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 years of age or older. Written informed consent provided. Histological or cytological confirmation of adenocarcinoma of the prostate. At least one previous hormonal treatment including LH-RH analogue and antiandrogen. Patients previously treated with an hormonal treatment must have evaluable disease progression defined by RECIST criteria. Karnofsky performance status ≥ 60%. Adequate hematologic (WBC ≥ 3,000/μl, ANC≥1,500/μl, platelet count ≥ 100,000/μl), hepatic (bilirubin level within normal limits, AST and ALT ≤ 1.5 x the upper normal limit) and renal functions (serum creatinine level ≤ 1.5 the upper limit of normal). Patients with reproductive potential must use effective contraception. Concurrent biphosphonates can be allowed provided treatment was initiated at least 4 weeks prior to study entry. Life expectancy of at least 6 months. |
|
E.4 | Principal exclusion criteria |
None previous medical antitumor therapy, while are allowed one or more chemotherapy regimen. Patients who have gone under surgery for any cause less than 4 weeks prior to study entry. Clinical evidence of brain metastases or history of brain metastases. Previous or current malignancies at other sites with the exception of adequately treated non melanoma skin cancer, and any other malignancies with an interval free from progression within 5 years. Current enrolment in another therapeutic clinical trial. Any other disease of SNC or PNS. A history of non compliance to medical regimen or inability or unwillingness to return for all scheduled visits. Is allowed radiotherapy on bone lesions whose are not the only parameter of disease. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the biochemical responses as determined by PSA value. |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
| |
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 | |
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 | 0 |