Trial Information
A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
January 2009
Safety Issue:
No
Principal Investigator
Howard J West, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Swedish Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
CRC 0639
NCT ID:
NCT00456716
Start Date:
March 2007
Completion Date:
December 2008
Related Keywords:
- Lung Cancer
- BAC lung cancer
- adenocarcinoma of the lung
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Lung Neoplasms
Name | Location |
Swedish Cancer Institute |
Seattle, Washington 98104 |