E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of adult patients with Gleevec (imatinib)-resistant CML in accelerated phase or blast crisis, relapsed/refractory Ph+ ALL; and sistemic mastocytosis and idiopatic hypereosinophilic syndrome. |
Trattamento di leucemia mieloide cronica Fiiladelfia positiva resistente a Glivec?, in fase accelerata o in crisi blastica; leucemia linfoblastica acuta Filadelfia positiva; sindrome ipereosinofila e mastocitosi sistemica |
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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 | 10009013 |
E.1.2 | Term | Chronic myeloid leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Indicazione: Leucemia Mieloide Cronica (CML) Valutare l?efficacia e la sicurezza d?impiego di AMN107 in pazienti con CLM resistente o intollerante a imatinib in crisi blastica, fase accelerata, o in fase cronica. Indicazione: Leucemia Linfoblastica Acuta (ALL Ph+) Valutare la sicurezza d?impiego e l?attivita' antitumorale preliminare di AMN107 in pazienti con ALL Ph+ refrattaria o in ricaduta. Indicazione: Sindrome Ipereosinofila Idiopatica (HES), Leucemia Eosinofila Cronica (CEL), Mastocitosi Sistemica ( SM) Valutare la sicurezza d?impiego e l?attivita' antitumorale preliminare di AMN107 in pazienti con HES/CEL e mastocitosi sistemica. |
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E.2.2 | Secondary objectives of the trial |
Indicaz:Leucemia Mieloide Cronica(CML)1.Valut,prima,durante e dopo la terapia,in cellule tumorali prelevate dal midollo osseo e/o dal sangue,le modificaz dei trascritti di Bcr- Abl mediante determinaz con Q-RT-PCR,le Variaz della proteina Crk-L mediante western blot e le modificazioni mutazionali di Bcr-Abl.2.Stud la farmacocinetica di AMN107.Indicaz:Leucemia Linfoblastica Acuta(ALL Ph+)1.Valut,prima,durante e dopo la terapia,in cellule tumorali prelevate dal midollo osseo e/o dal sangue,le modificazioni dei trascritti di Bcr-Abl mediante determinazioni con Q-RT-PCR e l?analisi mutazionale di Bcr-Abl.2.Stud la farmacocinetica di AMN107 Indicaz:Sindrome Ipereosinofila Idiopatica(HES)/Leucemia Eosinofila Cronica(CEL),Mastocitosi Sistemica(SM)1.Valut,prima,durante e dopo la terapia,in cellule tumorali prelevate dal midollo osseo e/o dal sangue,le Variaz della presenza di F1P1L1-PDGFRA mediante Q-RT-PCR e le modificazioni mutazionali di PDGFRA e c-Kit 2.Stud la farmacocinetica di AMN107 |
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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 | 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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 66 |
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 | No |
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 |
Australia |
Canada |
Hong Kong |
Korea, Republic of |
New Zealand |
Singapore |
Switzerland |
Taiwan |
Turkey |
United States |
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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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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 | 76 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 90 |
E.8.9.2 | In all countries concerned by the trial days | 0 |