E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication to surgery |
tumore squamocellulare della pelle localmente avanzato non resecabile o metastatico o con controindicazione clinica alla chirurgia |
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E.1.1.1 | Medical condition in easily understood language |
squamous cell cancer of the skin |
tumore squamocellulare della pelle |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040808 |
E.1.2 | Term | Skin cancer |
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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Response rate (partial response, PR + complete response, CR) |
Tasso di risposta (risposta parziale, RP + risposta completa, RC) |
|
E.2.2 | Secondary objectives of the trial |
-Compliance to the treatment and safety
-Disease control (stable disease (SD) + PR + CR)
-Progression-Free Survival (PFS) and Overall Survival (OS)
-Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
-Translational research
|
-Compliance al trattamento e sicurezza
-Controllo della malattia (stabilità di malattia + risposta parziale, RP + risposta completa, RC)
-Sopravvivenza libera da progressione (PFS) and sopravvivenza globale (OS)
-Percentuale di pazienti inizialmente ritenuti non operabili a causa della difficoltà di ottenere un trattamento curativo che dopo trattamento con dacomitinib si sottopongono ad intervento chirurgico
-Ricerca traslazionale |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Translational Research date 27 May 2014 Version 1.0
aiming at detecting molecular targets to predict response to treatment and therefore to improve the strategy of treatment. |
Ricerca Traslazionale data 27 Maggio 2014 Versione 1.0
finalizzata all’individuazione di target molecolari in grado di predire la risposta al trattamento e di conseguenza migliorare la strategia del trattamento stesso. |
|
E.3 | Principal inclusion criteria |
•Signed informed consent to treatment.
•Histological diagnosis of squamous cell carcinoma of the skin not amenable to surgical treatment with curative purposes or with clinical contraindication to surgery (examples of medical contraindications to surgery include but are not limited to:
- skin SCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
- anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
- anticipated difficulty in obtaining a curative resection due to the location of the tumour, the size of disease
- anticipated difficulty in reconstructing the area that will be surgically removed
- significant comorbidities that preclude the feasibility of a radical surgery
•Presence of measurable disease according to RECIST 1.1
•ECOG performance status 0-2.
•Age≥ 18 years.
•For men and women in the fertile period: the use of birth control systems during treatment.
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•Firma del consenso informato.
•Diagnosi istologica di carcinoma squamocellulare della pelle non suscettibile di trattamento chirurgico con finalità curativa con controindicazione clinica alla chirurgia (esempi di controindicazioni mediche alla chirurgia possono comprendere, senza limitarsi a:
- carcinoma squamocellulare della pelle recidivato nella stessa sede in seguito a due o più interventi chirurgici, la cui resezione a scopo curativo è ritenuta improbabile
- prevedibile esito patologico e/o deformità in seguito a chirurgia (ad esempio, rimozione di un’intera parte di una struttura facciale, come naso, orecchio, palpebra, occhio; o necessità dell’amputazione degli arti)
- prevedibile difficoltà nell’ottenere una resezione curativa a causa della posizione del tumore, della dimensione della malattia
- prevedibile difficoltà nel ricostruire l’area che verrà rimossa chirurgicamente
- comorbidità significativa che preclude la fattibilità di un intervento chirurgico
•Presenza di malattia misurabile secondo i criteri RECIST 1.1
•ECOG performance status 0-2.
•Età ≥ 18 anni.
•Per gli uomini e le donne in età fertile: utilizzo di un metodo anticoncezionale durante il periodo di trattamento
|
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E.4 | Principal exclusion criteria |
•Previous treatment with tyrosine kinase inhibitors or monoclonal antibodies directed against EGFR.
•Any toxicity CTC grade> 2 from previous treatments not yet resolved.
•Pregnant or breastfeeding
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•Trattamenti precedenti con inibitori della tirosin-kinasi con anticorpi monoclonali anti EGFR.
•Qualsiasi tossicità non ancora risolta di grado > 2 dai precedenti trattamenti secondo il CTCAE
•Donne in stato di gravidanza o allattamento
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Response rate (partial response, PR + complete response, CR) |
Tasso di risposta (risposta parziale, RP + risposta completa, RC) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Compliance to the treatment and safety
-Disease control (stable disease (SD) + PR + CR)
-Progression-Free Survival (PFS) and Overall Survival (OS)
-Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
-Translational research
|
-Compliance al trattamento e sicurezza
-Controllo della malattia (stabilità di malattia + risposta parziale, RP + risposta completa, RC)
-Sopravvivenza libera da progressione (PFS) and sopravvivenza globale (OS)
-Percentuale di pazienti inizialmente ritenuti non operabili a causa della difficoltà di ottenere un trattamento curativo che dopo trattamento con dacomitinib si sottopongono ad intervento chirurgico
-Ricerca traslazionale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
LVLS |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |