E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patients |
Tumori neuroendocrini gastro-entero-pancreatici avanzati, PET FDG negativi |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced gastro-entero-pancreatic Neuroendocrine Tumors |
Tumori neuroendocrini gastro-entero-pancreatici avanzati |
|
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 | 16.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10014713 |
E.1.2 | Term | Endocrine neoplasms malignant and unspecified |
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 |
The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels. |
L’obiettivo primario è di valutare la DCR e la tossicità come co-obiettivo primario a 2 differenti livelli di dose |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are PFS, late toxicity and OS. |
Gli obiettivi secondari sono la PFS, la tossicità tardiva e l’OS. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age >18 years.
- Patients must have histologically or cytologically confirmation of GEP–NETand Ki 67 index <= 20%.
- Measurable disease according to RECIST 1.1.criteria
- advanced GEP–NET are elegible; patients must have progressive disease based on RECIST 1.1. criteria
- Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
- FDG PET negative (SUV less than 2.5)
- ECOG <2
- No previous oncological treatments within 4 weeks
- No previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow
- signed informed consent
|
- Età >18 anni
- Conferma istologica o citologica di GEP–NET e Ki 67 <= 20%.
- Malattia misurabile secondo i RECIST 1.1.criteria
- Sono eligibili i pazienti con GEP–NET avanzato; i pazienti devono avere progression di malattia second i criteri RECIST 1.1.
- Un OctreoScan e/o una PET/CT con 68Ga-peptidi devono mostrare un uptake significativo al tumore
- FDG PET negativa (SUV inferior a 2.5)
- ECOG <2
- No precedenti trattamenti per la patologia oncologica entro 4 settimane
- No precedent trattamenti radiometabolici con una dose al rene superior a 25 Gy e superiore a 1,5 Gy al midollo
- consenso informato firmato
|
|
E.4 | Principal exclusion criteria |
- Ki 67 index > 20 %
- FDG PET positive at least in one documented lesion with a SUV more than 2.5
- Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
|
- Ki 67 > 20%
- FDG PET positiva (SUV > 2.5)
- precedente trattamento radiometabolico con una dose ai reni superiore a 25 Gy e superiore a 1,5 Gy al midollo
- patologie concomitanti non controllate
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to evaluate the DCR and the safety as co-primary objective at two different dosage levels. |
L’obiettivo primario è di valutare la DCR e la tossicità come co-obiettivo primario a 2 differenti livelli di dose |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
CT scan every 6 months, blood tests every 2 weeks |
TC ogni 6 mesi, esami del sangue ogni 2 settimane |
|
E.5.2 | Secondary end point(s) |
The secondary objectives are PFS, late toxicity and OS. |
Gli obiettivi secondari sono la PFS, la tossicità tardiva e l’OS. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
FUP visits with radiological evaluations and blood tests every 6 months |
visite di FUP con esami radiologici ed esami del sangue ogni 6 mesi |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
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) | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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
|
last patient last visit |
ultima visita ultimo paziente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |