Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

Lung Cancer Clinical Trial

Official title:

A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456716
• Other study ID #: CRC 0639
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2007
• Last updated: March 2, 2010
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Open label study of sorafenib

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Cancer

Intervention

Drug:
• sorafenib
400mg po bid

Locations

Country	Name	City	State
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Swedish Medical Center	Bayer, Onyx Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		January 2009	No
Primary	One-year survival		January 2009	No
Primary	Median survival		January 2009	No
Secondary	Median progression-free survival		January 2009	No
Secondary	Toxicities		January 2009	Yes