Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Intrapatient Dose-Escalation Study of Sorafenib in Advanced or Relapsed Non-Small Cell Lung Cancer (NSCLC)|
- Toleration of dose escalation (dose-limiting toxicities) [ Time Frame: One year ] [ Designated as safety issue: No ]
- Safety of sorafenib in dose-escalation (adverse events and serious adverse events) [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
sorafenib (400mg or 600mg or 800mg) by mouth twice daily, for 28 days
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.
|United States, Wisconsin|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Anne M Traynor, M.D.||University of Wisconsin, Madison|