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Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT00456716
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : March 4, 2010
Sponsor:
Collaborators:
Bayer
Amgen
Information provided by:
Swedish Medical Center

April 3, 2007
April 5, 2007
March 4, 2010
March 2007
December 2008   (Final data collection date for primary outcome measure)
  • Response rate [ Time Frame: January 2009 ]
  • One-year survival [ Time Frame: January 2009 ]
  • Median survival [ Time Frame: January 2009 ]
  • Response rate
  • One-year survival
  • Median survival
Complete list of historical versions of study NCT00456716 on ClinicalTrials.gov Archive Site
  • Median progression-free survival [ Time Frame: January 2009 ]
  • Toxicities [ Time Frame: January 2009 ]
  • Median progression-free survival
  • Toxicities
Not Provided
Not Provided
 
Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma
A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Open label study of sorafenib
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).
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
Drug: sorafenib
400mg po bid
Other Name: BAY 43-9006
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
24
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00456716
CRC 0639
No
Not Provided
Not Provided
Howard Jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
Swedish Medical Center
  • Bayer
  • Amgen
Principal Investigator: Howard J West, M.D. Swedish Cancer Institute
Swedish Medical Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP