NCT02268747

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Skin Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	Dacomitinib	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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2014-10-20
• Last updated: 2016-07-04

Locations

1 site across 1 country: Italy