Skin Squamous Cell Cancer Clinical Trial
Official title:
Efficacy and Safety of Single Agent Pan-HER Inhibitor Dacomitinib in the Treatment of Locally Advanced Unresectable or Metastatic Squamous Cell Cancer of the Skin or With Clinical Contraindication to Surgery
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.
The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin
toxicity will be of grade <2, then the patients will start dacomitinib at 45 mg once daily
and they will be clinically assessed every cycle (i.e. every 28 days).
If the highest skin toxicity will be grade >2, then the patient will interrupt the treatment
following the criteria for dose reduction.
Tumor evaluation will be performed at baseline and every other cycle. Response will be
assessed according to RECIST 1.1. The patient will continue to assume the study drug until
disease progression, unacceptable toxicity or any medical condition that will suggest to
stop the treatment for patient's safety
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment