Overview

Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer

Status:
Unknown status
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER inhibitor, in unresectable or metastatic skin SCC. HER2 expression is common in skin SCC, being reported with high rates, even if in small studies. Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it could be associated with the malignant phenotype. In this frame Dacomitinib could play a role in the increase of the response rate.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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

- Ageā‰„ 18 years

- For men and women in the fertile period: the use of birth control systems during
treatment

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