Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02268747
Recruitment Status : Unknown
Verified July 2016 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.


Condition or disease Intervention/treatment Phase
Skin Squamous Cell Cancer Drug: Dacomitinib Phase 2

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: 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.

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.

Other Name: PF-00299804




Primary Outcome Measures :
  1. Response rate to Dacomitinib [ Time Frame: 24 months ]
    Response rate (partial response, PR + complete response, CR) to Dacomitinib


Secondary Outcome Measures :
  1. Compliance to the treatment and safety [ Time Frame: 24 months ]
    Compliance to the treatment and safety

  2. Disease control [ Time Frame: 24 months ]
    Disease control (stable disease (SD) + PR + CR)

  3. PFS and OS [ Time Frame: 24 months ]
    Progression-Free Survival (PFS) and Overall Survival (OS)

  4. 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 ]
    Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib


Other Outcome Measures:
  1. Analysis of mutational/gene expression [ Time Frame: 24 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268747


Locations
Layout table for location information
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Layout table for investigator information
Principal Investigator: Paolo Bossi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Layout table for additonal information
Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02268747     History of Changes
Other Study ID Numbers: DACOMINT14
92/14 ( Other Identifier: INT )
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
skin squamous cell cancer panHER inhibitor Dacomitinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma