Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

This study has been completed.
Sponsor:
Collaborators:
Bayer
Onyx Pharmaceuticals
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00456716
First received: April 3, 2007
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456716

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

Additional Information:
No publications provided

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
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:
Lung Neoplasms
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014