E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced pancreatic cancer |
Tumore al pancreas localmente avanzato |
|
E.1.1.1 | Medical condition in easily understood language |
Locally Advanced Pancreatic Cancer |
Tumore al pancreas localmente avanzato |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033606 |
E.1.2 | Term | Pancreatic cancer non-resectable |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
To evaluate the time to treatment failure in LAPC subjects treated with nab-paclitaxel plus gemcitabine as induction therapy followed by Investigator’s Choice of treatment |
Valutare il tempo al fallimento del trattamento in pazienti con LAPC trattati con nab-paclitaxel più gemcitabina come terapia di induzione seguita dal trattamento scelto dallo Sperimentatore |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate the disease control rate (DCR) after the first 6 cycles of nab-paclitaxel
plus gemcitabine
-To evaluate the overall response rate (ORR)
-To evaluate the overall progression-free survival (PFS) and overall survival (OS)
-To assess the overall safety profile
-To evaluate the subject’s health-related quality of life (QoL) |
Valutare il tasso di controllo della malattia (DCR) dopo i primi 6 cicli di nab-paclitaxel più gemcitabina
•- Valutare il tasso di risposta globale (ORR)
•-Valutare la sopravvivenza libera da progressione (PFS) globale e la sopravvivenza globale (OS)
•-Valutare il profilo di sicurezza globale
•-Valutare la qualità di vita (QoL) correlata alla salute del soggetto |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
•No prior anticancer therapy for pancreatic cancer
•≥ 18 years of age with a performance status of 0 or 1
•Adequate complete blood counts, hepatic function, and renal function
•Signed informed Consent
|
•Pazienti oncologici con adenocarcinoma pancreatico non metastatico, non resecabile
•Nessuna precedente terapia antitumorale per il cancro del pancreas
•Età ≥ 18 anni con un performance status di 0 o 1
•Conte ematiche complete, funzione epatica e funzione renale adeguate
•Consenso informato firmato
|
|
E.4 | Principal exclusion criteria |
•Active bacterial, viral, or fungal infection
•Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
•Subjects with sensory neuropathy, ascites, or plastic biliary stent.
•Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
•Women who are pregnant or breast feeding
|
•Infezione attiva di origine batterica, virale o fungina
•Infezione con epatite B o C, o anamnesi di infezione da virus dell’immunodeficienza umana (HIV) o attuale trattamento con immunosoppressori o mielosoppressori
•Soggetti con neuropatia sensoriale, ascite o stent biliare in plastica.
•Gravi fattori di rischio medico che interessano uno qualsiasi dei sistemi organici principali o disturbi psichiatrici gravi (inclusi, in via non limitativa, disturbi del tessuto connettivo, malattia polmonare, disturbi cardiaci o epilettici)
•Donne in gravidanza o allattamento
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to treatment failure |
Tempo al fallimento del trattamento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time after the first dose of study therapy to treatment failure |
Tempo al fallimento del trattamento dopo la prima dose della terapia dello studio |
|
E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints:
1. DCR after 6 cycles of nab-paclitaxel plus gemcitabine
2. ORR
3. PFS
4. OS
5. differences in outcomes from baseline
Secondary safety endpoint:
- incidence of treatment-emergent AEs, SAEs, laboratory abnormalities and other safety parameters |
1. DCR dopo 6 cicli di nab-paclitaxel più gemcitabina
2. ORR
3. PFS
4. OS
5. differenze negli esiti rispetto al basale
Endpoint di sicurezza secondario:
- incidenza di AE, SAE, anomalie nei risultati di laboratorio e altri parametri di sicurezza derivanti dal trattamento
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary efficacy endpoints:
1. defined as the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit
2. defined as the combined incidence of CR and PR
3. defined as the time after the first dose of study therapy to disease progression or death (by any cause)
4. defined as the time after the first dose of study therapy to death (by any cause)
5. during treatment, and after treatment with nab-paclitaxel plus gemcitabine for the EORTC quality of life questionnaires, EORTC QLQC30 and QLQ-PAN26
Secondary safety endpoint:
- After signing ICF and until 28 days after the last dose of IP or 28-day Followup Visit, whichever occurs later. Not during survival unless it is a suspected SAE. |
•Endpoint di efficacia secondari:
•definiti come l’incidenza combinata di risposta completa, risposta parziale e malattia stabile misurati in sede di visita di fine trattamento
•definiti come l’incidenza combinata di CR e PR
•definiti come il tempo alla progressione della malattia o al decesso (per qualsiasi causa) dopo la prima dose della terapia dello studio
•definiti come il tempo al decesso (per qualsiasi causa) dopo la prima dose della terapia dello studio
•durante e dopo il trattamento con nab-paclitaxel più gemcitabina per i questionari EORTC sulla qualità di vita, EORTC QLQC30 e QLQ-PAN26
Endpoint di sicurezza secondario:
•Dopo aver firmato l’ICF e fino a 28 giorni dopo l’ultima dose dell’IP o alla visita di follow-up a 28 giorni, a seconda di quale evento si verifichi ..... |
|
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 | No |
E.6.10 | Pharmacogenetic | No |
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 | 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) | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
Canada |
France |
Italy |
Spain |
United States |
|
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
|
The End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date. |
La fine della sperimentazione è definita come la data dell’ultima visita dell’ultimo soggetto che completa lo studio o la data di ricezione dell’ultimo dato raccolto relativo all’ultimo soggetto, necessario per l’analisi primaria, secondaria e/o esplorativa, come prestabilito nel protocollo e/o nel piano di analisi statistica, a seconda di quale sia la data più tardiva. |
|
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 | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |