Skin Squamous Cell CancerPhase 2NCT02268747
Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer
A Phase 2 study testing Dacomitinib in people with Skin Squamous Cell Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Squamous Cell Cancer
- What is being tested?
- Dacomitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, 20133
About this study
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
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.
Read the 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
- Being tested
- Dacomitinib
- Keywords
- skin squamous cell cancer panHER inhibitor Dacomitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacomitinibDrug
Also called PF-00299804
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to Dacomitinib
Response rate (partial response, PR + complete response, CR) to Dacomitinib
Measured: 24 months
Secondary outcomes (4)
Compliance to the treatment and safety
Compliance to the treatment and safety
Measured: 24 months
Disease control
Disease control (stable disease (SD) + PR + CR)
Measured: 24 months
PFS and OS
Progression-Free Survival (PFS) and Overall Survival (OS)
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Bossi, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268747
- Sponsor's protocol ID
- DACOMINT14
- Other IDs
- 92/14
- Status last verified
- Jul 2016
- First submitted
- 9 Aug 2014
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02268747
- Acronym / sponsor ID
- DACOMINT14
- Conditions
- Skin Squamous Cell Cancer
- Keywords
- skin squamous cell cancer panHER inhibitor Dacomitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dacomitinib | Experimental | Drug: DacomitinibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DacomitinibAlso: PF-00299804The 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 |
Primary outcome
Response rate to Dacomitinib
Time frame: 24 months
Response rate (partial response, PR + complete response, CR) to Dacomitinib
4 secondary outcomes
Compliance to the treatment and safety
Time frame: 24 months
Disease control
Time frame: 24 months
PFS and OS
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
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bossi, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dacomitinib in people with Skin Squamous Cell Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate to Dacomitinib (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.