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OpenTrials
Completed

NCT Number: NCT00456716

Sorafenib in BAC or Never-Smokers With Lung Adenocarcinoma

Open label study of sorafenib

Completed

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib

Drug

400mg po bid

Other names: BAY 43-9006

Primary outcomes

  1. Response rate

    Time frame: January 2009

  2. One-year survival

    Time frame: January 2009

  3. Median survival

    Time frame: January 2009

Secondary outcomes

  1. Median progression-free survival

    Time frame: January 2009

  2. Toxicities

    Time frame: January 2009

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Collaborators

  • Amgen
  • Bayer

Registry information

Official study title

A Phase II Trial of Sorafenib in BAC or Never-Smokers With Any Lung Adenocarcinoma

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2007
Registry last updated
Mar 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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