E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
trattamento del mesotelioma pleurico maligno avanzato resistente al trattamento con penetrexed/sale di platino |
trattamento del mesotelioma pleurico maligno avanzato resistente al trattamento con penetrexed/sale di platino |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059518 |
E.1.2 | Term | Pleural mesothelioma malignant |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
Paragonare la sopravvivenza globale associata alla terapia con L-001079038 piu' la migliore terapia di supporto con quella associata al trattamento con placebo piu' la migliore terapia di supporto per il trattamento di pazienti con mesotelioma maligno pleurico avanzato per i quali la chemioterapia precedente, che includeva pemetrexed in combinazione con cisplatino o carboplatino, e' fallita e determinare la sicurezza globale e la tossicita' di L-001079038 in questa popolazione di pazienti. |
|
E.2.2 | Secondary objectives of the trial |
Paragonare L-001079038 piu' la migliore terapia di supporto con placebo piu' la migliore terapia di supporto nel trattamento di pazienti con mesotelioma pleurico maligno avanzato la cui chemioterapia precedente,che includeva pemetrexed in combinazione con cisplatino o carboplatino,e' fallita rispetto a: (1) il tasso di risposta obiettiva globale; (2) il tempo alla progressione; (3) punteggio della dispnea sulla scala dei sintomi del carcinoma polmonare modificata per il mesotelioma (LCSS-Meso) alla Settimana 12; e (4) percentuale di cambiamento dal basale della capacita' vitale forzata (FVC) alla settimana 12. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | |
E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Yes |
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 | Yes |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 14 |