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

Primary Purpose

Skin Squamous Cell Cancer

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Dacomitinib
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Squamous Cell Cancer focused on measuring skin squamous cell cancer panHER inhibitor Dacomitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dacomitinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate to Dacomitinib
Response rate (partial response, PR + complete response, CR) to Dacomitinib

Secondary Outcome Measures

Compliance to the treatment and safety
Compliance to the treatment and safety
Disease control
Disease control (stable disease (SD) + PR + CR)
PFS and OS
Progression-Free Survival (PFS) and Overall Survival (OS)
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib

Full Information

First Posted
August 9, 2014
Last Updated
July 1, 2016
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT02268747
Brief Title
Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Squamous Cell Cancer
Keywords
skin squamous cell cancer panHER inhibitor Dacomitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dacomitinib
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Dacomitinib
Other Intervention Name(s)
PF-00299804
Intervention 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.
Primary Outcome Measure Information:
Title
Response rate to Dacomitinib
Description
Response rate (partial response, PR + complete response, CR) to Dacomitinib
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Compliance to the treatment and safety
Description
Compliance to the treatment and safety
Time Frame
24 months
Title
Disease control
Description
Disease control (stable disease (SD) + PR + CR)
Time Frame
24 months
Title
PFS and OS
Description
Progression-Free Survival (PFS) and Overall Survival (OS)
Time Frame
24 months
Title
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
Description
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Analysis of mutational/gene expression
Description
Translational research regarding the analysis of pERK, Ki67, pSTAT3 p27, pEGFR and other mutational/gene expression analysis to be determined within the study period. Correlation of immunohistochemistry analysis of these markers and response to treatment or to onset of acquired resistance.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Bossi, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
City
Milan
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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