Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00456716
• Lead Sponsor: Swedish Medical Center

Brief Summary

Open label study of sorafenib

Detailed Description

Open label study using oral sorafenib 800 mg daily in any stage III-IV BAC lung cancer and Stage III-IV adenocarcinoma of the lung in nonsmokers (less than \< 100 cigarettes lifetime).

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Age > 18
• Life expectancy > 12 weeks
• Biopsy-proven BAC or adenocarcinoma
• Willing to provide smoking status
• Selected IIIB or stage IV cancer that is incompletely resected or unresectable

Exclusion Criteria

• O2 saturation < 88% on room air
• Pregnant or nursing women
• Surgery or radiation therapy within 4 weeks of starting study
• Major heart condition within 6 months of starting therapy
• Certain concomitant medications prohibited

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	January 2009
One-year survival	January 2009
Median survival	January 2009

Secondary Outcome Measures

Name	Time	Method
Median progression-free survival	January 2009
Toxicities	January 2009

Trial Locations

Locations (1)

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States