Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

This study has been completed.
Onyx Pharmaceuticals
Information provided by:
Swedish Medical Center Identifier:
First received: April 3, 2007
Last updated: March 2, 2010
Last verified: March 2010
Open label study of sorafenib

Condition Intervention Phase
Lung Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • One-year survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Median survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median progression-free survival [ Time Frame: January 2009 ] [ Designated as safety issue: No ]
  • Toxicities [ Time Frame: January 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sorafenib
    400mg po bid
    Other Name: BAY 43-9006
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).

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00456716

United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Onyx Pharmaceuticals
Principal Investigator: Howard J West, M.D. Swedish Cancer Institute
  More Information

Additional Information:
Responsible Party: Howard Jack West, M.D., Swedish Medical Center, Swedish Cancer Institute Identifier: NCT00456716     History of Changes
Other Study ID Numbers: CRC 0639 
Study First Received: April 3, 2007
Last Updated: March 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
BAC lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors processed this record on May 30, 2016