Spots Global Cancer Trial Database for Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer

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Trial Identification

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

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

Study ID: NCT00954278

Conditions

Carcinoma, Non Small Cell Lung

Interventions

sorafenib

Study Description

Brief 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.

Detailed 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.