Trial ID or NCT#

NCT00064350

Status

not recruiting iconNOT RECRUITING

Purpose

RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different human tumor types including colon, pancreatic, lung, and ovarian. This activity was cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is suspended while the drug is administered but returns to baseline rates when the agent is withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized discontinuation design was adopted in the present trial, conducted in a population who were potentially sensitive to sorafenib. PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works compared to placebo in treating patients with refractory non-small cell lung cancer.

Official Title

A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Harlan Pinto
Harlan Pinto
Medical oncologist, Head and neck specialist
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Professor of Medicine (Oncology)

Contact us to find out if this trial is right for you.

CONTACT

Lisa Zhou
(650) 736-4112