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Phase 2
18 Years
Open (Enrolling)
Squamous Cell Carcinoma

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Trial Information

Inclusion Criteria

Inclusion criteria:

- 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

Exclusion criteria:

- 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)

- Poorly controlled hypertension

- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Macroscopic evaluation of tumour response

Outcome Description:

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).

Outcome Time Frame:

84 days

Safety Issue:


Principal Investigator

Reinhard Dummer, Professor MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Dermatology


Switzerland: Swissmedic

Study ID:




Start Date:

June 2012

Completion Date:

June 2013

Related Keywords:

  • Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell