locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication to surgery MedDRA version: 17.0 Level: PT Classification code 10040808 Term: Skin cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: DACOMITINIB
Product Code: PF-00299804
Pharmaceutical Form: Film-coated tablet
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (partial response, PR + complete response, CR) ;Secondary Objective: -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 ;Primary end point(s): Response rate (partial response, PR + complete response, CR) ;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactClinica Trial Office
Fondazione IRCCS Istituto Nazionale dei Tumori
Outcome results
None listed