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Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer

Carcinoma, Non Small Cell Lung Clinical Trial

Official title:
A Phase I, Intrapatient Dose-Escalation Study of Sorafenib in Advanced or Relapsed Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Summary

The purpose of this study is to determine the number of patients with advanced, relapsed non-small cell lung cancer who can tolerate dose escalation sorafenib from 400 mg twice daily to either 600 mg twice daily or 800 mg twice daily. Safety and tolerability of sorafenib will also be examined.

Clinical Trial Description

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality in the U.S. Time to progression in advanced disease remains poor and further study of newer agents with novel mechanisms of action is needed to improve duration and quality of life for NSCLC patients.

Sorafenib is an oral-multi-kinase inhibitor with effects on tumor proliferation and tumor angiogenesis. Sorafenib has demonstrated activity in preclinical models of NSCLC both in combination with chemotherapy and as monotherapy. A recent intra-patient dose escalation trial of sorafenib in renal cell carcinoma showed positive response rates and tolerability up to 1200mg in 91% of patients.

This study attempts a similar dose-escalation of sorafenib in NSCLC patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00954278
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase Phase 1
Start date July 28, 2009
Completion date December 23, 2015
View Details
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