NCT01666431

Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Lapatinib

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-08-16
• Last updated: 2014-12-03

Locations

1 site across 1 country: Switzerland