A Phase I, Intrapatient Dose-Escalation Study of Sorafenib in Advanced or Relapsed Non-Small Cell Lung Cancer (NSCLC)
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toleration of dose escalation (dose-limiting toxicities)
Anne M Traynor, M.D.
University of Wisconsin, Madison
United States: Institutional Review Board
|University of Wisconsin - Madison||Madison, Wisconsin 53792|