Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01666431
Status:
TERMINATED
Last Update Posted:
2014-12-03
First Post:
2012-08-08
Brief Title:
Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None