Efficacy and safety of Dacomitinib in the treatment of locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication to surgery

Phase 1

• Conditions: locally advanced unresectable or metastatic squamous cell cancer of the skin or with clinical contraindication to surgery; MedDRA version: 17.0Level: PTClassification code 10040808Term: Skin cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002175-28-IT
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-13
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 43

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate (partial response, PR + complete response, CR) ;Secondary Objective: -Compliance to the treatment and safety<br>-Disease control (stable disease (SD) + PR + CR) <br>-Progression-Free Survival (PFS) and Overall Survival (OS)<br>-Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib<br>-Translational research <br>;Primary end point(s): Response rate (partial response, PR + complete response, CR) ;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Compliance to the treatment and safety<br>-Disease control (stable disease (SD) + PR + CR) <br>-Progression-Free Survival (PFS) and Overall Survival (OS)<br>-Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib<br>-Translational research <br>;Timepoint(s) of evaluation of this end point: 24 months