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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

January 2009

Safety Issue:

No

Principal Investigator

Howard J West, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CRC 0639

NCT ID:

NCT00456716

Start Date:

March 2007

Completion Date:

December 2008

Related Keywords:

  • Lung Cancer
  • BAC lung cancer
  • adenocarcinoma of the lung
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms

Name

Location

Swedish Cancer InstituteSeattle, Washington  98104