E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
glioblastoma |
glioblastoma |
|
E.1.1.1 | Medical condition in easily understood language |
brain cancer |
tumore cerebrale |
|
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 | 10018336 |
E.1.2 | Term | Glioblastoma |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
overall survival |
sopravvivenza globale |
|
E.2.2 | Secondary objectives of the trial |
PK of LY2157299 monohydrate. Evaluate Safety Prognostic and predictive marker assessment Progression-free survival , median OS and PFS, OS and PFS rates at 6 months Tumor response rate Assess patient-reported symptoms and neurocognitive function |
farmacocinetica di LY2157299 monohydrate;sicurezza;valutazione dei marker prognostici e predittivi; PFS, OS e PFS mediana, tasso di OS e PFS a 6 mesi; tasso di risposta tumorale; Valutare i sintomi soggettivi e la funzione neurocognitiva |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients at or older than 18 years and who have relapsed Glioblastoma after first-line treatment with chemoradiation, have measureable disease (response to be based on RANO criteria), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 |
pazienti maschi e femmine a partire dai 18 anni di età che hanno subito una recidiva di GB dopo una terapia di prima linea con radio-chemioterapia, che presentano una malattia misurabile (sulla base dei criteri RANO), e stato di validità di 0 o 1 secondo l’ECOG (Eastern Cooperative Oncology Group). |
|
E.4 | Principal exclusion criteria |
Moderate or severe cardiac condition. Prior treatment with nitrosurea. Prior treatment with bevacizumab as part of a first-line treatment for GB, Serious concomitant systemic disorder, Current acute or chronic myelogenous leukemia, Second primary malignancy, Pregnant or breastfeeding women |
condizione cardiaca moderata o severa; precedente trattamento con bevacizumabcome come trattamento di prima linea per glioblastoma; grave malattia sistemica concomitante; leucemia mieloide acuta o cronica in corso; secondo tumore maligno primario; gravidanza o allattamento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
overall survival |
sopravvivivenza globale |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Date of randomization to the date of death from any cause |
dalla randomizzazione al decesso per qualsiasi causa |
|
E.5.2 | Secondary end point(s) |
Progression-free survival and PFS rate at 6 months, 9 months, 12 months Median OS and at 6 months Tumor response rate PK of LY2157299 monohydrate. Evaluate Safety Prognostic and predictive marker assessment Tumor response rate RANO criteria Change in patient-reported symptoms and neurocognitive function |
PFS e tasso di PFS 6, 9 e 12 mesi; OS mediana e a 6 mesi; tasso di risposta tumorale; farmacocinetica di LY2157299 monohydrate; sicurezza; valutazione dei marker prognostici e predittivi; tasso di risposta tumorale (RANO criteria); variazione dei sintomi soggettivi e della funzione neurocognitiva. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PFS - Every 2 cycles (8 weeks) from start of treatment until documented disease progression or death from any cause. RR - Baseline to disease progression PK – Cycle 1 ( Day,1,3,14,15,16) Safety – Every Cycle until study discontinuation Patient-reported symptoms and neurocognitive function - Every 2 cycles (8 weeks) from baseline until study discontinuation Prognostic and predictive marker assessment Cycle 1 |
PFS:ogni 2 cicli (8 settimane) dall'inizio del trattamento fino a progressione o decesso; RR: dal baseline alla progressione; farmacocinetica: ciclo 1 (giorno 1,3,14,15,16); sicurezza: ogni ciclo fino a interruzione; sintomi soggettivi e funzione neurocognitiva: ogni 2 cicli (8 settimane) dal baseline fino a interruzione; valutazione dei marker prognostici e predittivi: ciclo 1. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 13 |
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 | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |