NCT02268747

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

August 9, 2014

Last Update Submit

July 1, 2016

Conditions

Skin Squamous Cell Cancer

Keywords

skin squamous cell cancer panHER inhibitor Dacomitinib

Outcome Measures

Primary Outcomes (1)

  • Response rate to Dacomitinib

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

    24 months

Secondary Outcomes (4)

  • Compliance to the treatment and safety

    24 months

  • Disease control

    24 months

  • PFS and OS

    24 months

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

    24 months

Other Outcomes (1)

  • Analysis of mutational/gene expression

    24 months

Study Arms (1)

Dacomitinib

EXPERIMENTAL

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

Interventions

DacomitinibDRUG

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.

Also known as: PF-00299804
Dacomitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Milan, Italy, 20133, Italy

Location

MeSH Terms

Interventions

dacomitinib

Study Officials

  • Paolo Bossi, MD

    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2014

First Posted

October 20, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

IT(1)