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

NCT ID: NCT02268747

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dacomitinib

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.

Group Type: EXPERIMENTAL

Dacomitinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PF-00299804

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Bossi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, Italy, Italy

Countries

Italy

Other Identifiers

92/14

Identifier Type: OTHER

Identifier Source: secondary_id

DACOMINT14

Identifier Type: -

Identifier Source: org_study_id