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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

Brief Summary:
Open label study of sorafenib

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: sorafenib Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: sorafenib
    400mg po bid
    Other Name: BAY 43-9006


Primary Outcome Measures :
  1. Response rate [ Time Frame: January 2009 ]
  2. One-year survival [ Time Frame: January 2009 ]
  3. Median survival [ Time Frame: January 2009 ]

Secondary Outcome Measures :
  1. Median progression-free survival [ Time Frame: January 2009 ]
  2. Toxicities [ Time Frame: January 2009 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456716


Locations
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Bayer
Amgen
Investigators
Principal Investigator: Howard J West, M.D. Swedish Cancer Institute

Responsible Party: Howard Jack West, M.D., Swedish Medical Center, Swedish Cancer Institute
ClinicalTrials.gov Identifier: NCT00456716     History of Changes
Other Study ID Numbers: CRC 0639
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action