E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced metastatic prostatic carcinoma |
|
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 | 10036909 |
|
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 percentage of patients free of progression (biochemical and/or instrumental) after 12 weeks of treatment with metronomic Vinorelbine and Dexamethasone |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the variations of serum PSA levels from baseline after 12 weeks of treatment - To evaluate the antitumor activity in terms of objective response rate, according to modified RECIST criteria (PCWG2, Scher et al JCO 2008) - To evaluate the antitumor activity on bone metastases according to PCWG2 criteria (Scher et al JCO 2008) - To evaluate the toxicity profile of the treatment - To evaluate the time to biochemical and objective progression (PFS) - To evaluate the overall survival (OS) - To evaluate the quality of life (QoL) and pain control - To evaluate the Pharmacokinetic profile of Vinorelbine and its metabolite, 4-0-deacetil-Vinorelbine, during metronomic treatment - To evaluate the variations of plasma VEGF, TSP-1 and VEGFR-2 levels during treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of metastatic or locally advanced castration-resistant prostate adenocarcinoma, - Failure of previous docetaxel-based chemotherapy or patient unable to receive chemotherapy with docetaxel - Increasing PSA serum levels in three consecutive measuraments at least 1 week apart - PSA serum value ≥ 2 ng/mL - Serum Testosterone < 50 ng/dL (< 1.7 mmol/L) - ECOG PS ≤ 2 - Life expectancy ≥ 3 months - Adequate renal function (serum creatinine level < 1.25 upper normal limit) - Adequate liver function (serum total bilirubin level < 1.5 upper normal limit, aspartate aminotransferasi and alanine aminotransferasi < 3 upper limit) - Adequate bone marrow function (leukocytes > 3000/ mL, platelets > 100000/mL, haemoglobin level > 10 g/dL) - Interruption of antiandrogen therapy at least 4-8 weeks before enrollment, without biochemical response at time of suspension, in the absence of clinical or instrumental evidence of disease progression - Written informed consent |
|
E.4 | Principal exclusion criteria |
- Uncontrolled metabolic diseases or active infections - One of the following condition in the 12 months before the enrollment: - Miocardial infarction - Severe or unstable angina - Congestive heart failure - Pulmonary embolism, stroke, transient ischemic attack - Cardiac arrhythmias - QT interval > 450 msec - Coronary or periferic arterial bypass - Uncontrolledi hyperthension - Anticoaugulant treatment - Brain metastases - Second malignancies, except skin basal cell carcinoma |
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E.5 End points |
E.5.1 | Primary end point(s) |
- To evaluate the percentage of patients free of progression (biochemical and/or instrumental) after 12 weeks of treatment with metronomic Vinorelbine and Dexamethasone |
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | 5 |
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 | 6 |
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 | 6 |