Back to resultsSorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring BAC lung cancer, adenocarcinoma of the lung
Eligibility Criteria
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
Sites / Locations
- Swedish Cancer Institute
Outcomes
Primary Outcome Measures
Response rate
One-year survival
Median survival
Secondary Outcome Measures
Median progression-free survival
Toxicities
Full Information
NCT ID
NCT00456716
First Posted
April 3, 2007
Last Updated
March 2, 2010
Sponsor
Swedish Medical Center
Collaborators
Bayer, Amgen
1. Study Identification
Unique Protocol Identification Number
NCT00456716
Brief Title
Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
Official Title
A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
Bayer, Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
BAC lung cancer, adenocarcinoma of the lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
BAY 43-9006
Intervention Description
400mg po bid
Primary Outcome Measure Information:
Title
Response rate
Time Frame
January 2009
Title
One-year survival
Time Frame
January 2009
Title
Median survival
Time Frame
January 2009
Secondary Outcome Measure Information:
Title
Median progression-free survival
Time Frame
January 2009
Title
Toxicities
Time Frame
January 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard J West, M.D.
Organizational Affiliation
Swedish Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
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