E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Newly diagnosed Glioblastoma |
Glioblastoma Multiforme di nuova diagnosi |
|
E.1.1.1 | Medical condition in easily understood language |
Malignant brain tumor at diagnosis |
Tumori cerebrali maligni all'esordio |
|
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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018337 |
E.1.2 | Term | Glioblastoma multiforme |
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 |
Activity of the combination treatment with Clorpromazina plus standard regimen (Stupp) |
Attività della combinazione del farmaco Clorpromazina associato al trattamento standard (Stupp) |
|
E.2.2 | Secondary objectives of the trial |
Tolerability quality of life overall survival |
Tollerabilità Qualità di vita Sopravvivenza |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1- Newly diagnosed histologically-confirmed supra-tentorial GBM (World Health Organization grade IV) patients. Whenever feasible, patients will undergo maximal surgical resection or debulking, although patients with inoperable glioblastomas are also eligible. 2- Patients undergone complete standard concomitant chemoradiotherapy with TMZ. 3-Patients with provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. 4- Additional eligibility criteria include: age between 18 and 70; Karnofsky Performance Status (KPS) score of 70 or higher; adequate kidney, liver, bone marrow, and cardiac function; total serum bilirubin level and liver- function values; IDH1/2 mutational status; MGMT methylation status assessment. |
1. Pazienti affetti da GBM di nuova diagnosi con diagnosi confermata istologicamente (WHO grado IV) dopo asportazione chirurgica o biopsia, con stato di metilazione dell’enzima MGMT negativo (non ipermetilato) e dopo trattamento di radio-chemioterapia. 2- Pazienti che hanno completato il trattamento standard di radio-chemioterapia 3-Pazienti che hanno sottoscritto il consenso informato scritto prima dell’ingresso nello studio. 4- Età tra i 18 e i 70 anni; Karnofsky Performance Status (KPS) superiore a 70; normale funzionalità epatica e renale; |
|
E.4 | Principal exclusion criteria |
1. Treatment with any of the following: • Any other chemotherapy, immunotherapy or anticancer agents within 4 weeks before enrollment in the study. • Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment. • methylatedMGMT status.
2. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including: uncontrolled hypertension; active bleeding diatheses; active HBV, HCV or HIV infection. Screening for chronic conditions is not required; inadequate bone marrow reserve or organ function, as demonstrated by laboratory parameters. 3. Judgment by the investigator that the patient should not participate at the study if the patient is unlikely to comply with study procedures, restrictions and requirements. 4. Contraindications to MRI and or MRS. 5. Patients not able to sign the informed consent. |
1. Precedenti trattamenti con: - chemioterapie, immunoterapie o altri agenti antitumorali nelle 4 settimane precedenti. - partecipazione a precedenti studi clinici terapeutici nei 30 giorni precedenti - metilazione dell'MGMT 2. Qualsiasi evidenza di comorbidità severa 3. Non adeguata compliance del paziente 4. Controindicazioni a RM e spettroscopia 5. Pazienti non in grado di firmare il consenso |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression-Free Survival (PFS-6) |
Progression-Free Survival a 6 mesi |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
toxicity; Quality of life (EQ5) |
tossicità del trattamento combinato; Qualità di vita (EQ5) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every cycle; Every 3 cycles |
Ogni ciclo; Ogni 3 cicli |
|
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 36 |
E.8.9.2 | In all countries concerned by the trial days | 10 |