Squamous Cell CarcinomaPhase 2NCT01666431
Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
A Phase 2 study testing Lapatinib in people with Squamous Cell Carcinoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Nov 2013
- 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
- Age ≥ 18 years
- Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
- In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
- All included patients must have both FFPE and frozen material available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ system function
Who cannot join
- Subjects who have current active hepatic or biliary disease
- Other non-controlled malignancy
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
- Presence of uncontrolled infection
- History of any one or more of the following cardiovascular conditions within the past 6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
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- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Prior exposure to the study drug lapatinib
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.
Primary Objectives:
Read more
To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).
Secondary Objectives:
- To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
- To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
- Trial with medicinal product
- Conditions
- Squamous Cell Carcinoma
- Being tested
- Lapatinib
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LapatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib | Other | Not described Receives: Drug: Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopic evaluation of tumour response
The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
Measured: 84 days
Secondary outcomes (2)
Evaluation of tolerability
Evaluation of tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period
Measured: 84 days
Molecular evaluation of tumour response
Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinhard Dummer, Professor MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666431
- Sponsor's protocol ID
- SZ10ON03
- Status last verified
- Dec 2014
- First submitted
- 8 Aug 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
- ClinicalTrials.gov ID
- NCT01666431
- Acronym / sponsor ID
- SZ10ON03
- Conditions
- Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Aug 2012 (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.
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.
Primary Objectives:
To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).
Secondary Objectives:
- To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
- To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib | Other | Drug: Lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
- In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
- All included patients must have both FFPE and frozen material available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Subjects who have current active hepatic or biliary disease
- Other non-controlled malignancy
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
- Presence of uncontrolled infection
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 |
|---|---|---|
| Lapatinib | Drug | Lapatinib |
Primary outcome
Macroscopic evaluation of tumour response
Time frame: 84 days
The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
2 secondary outcomes
Evaluation of tolerability
Time frame: 84 days
Molecular evaluation of tumour response
Time frame: 84 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Reinhard Dummer, Professor MD principal investigator
University Hospital Zurich, Division of Dermatology
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 Lapatinib in people with Squamous Cell Carcinoma, run by University of Zurich at 1 site in Switzerland.
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 10 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: stopped early, as of the sponsor's last update on 3 Dec 2014. 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 Switzerland. 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?
The study was stopped early. 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?
Macroscopic evaluation of tumour response (time frame: 84 days). 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 3 Dec 2014.