Status:
UNKNOWN
Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Skin Squamous Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02268747
Start Date
November 1 2014
End Date
November 1 2016
Last Update
July 4 2016
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, Italy, 20133