Phase II Study of Dasatinib in Non Small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or
recurrent non-small cell lung cancer treated with dasatinib.
SECONDARY OBJECTIVES:
I. Determine the rate of response in patients treated with this drug. II. Examine the
relationship between clinical response to this drug and epidermal growth factor receptor
(EGFR) mutational status, EGFR copy number, and pSrc expression levels in pre-treatment
tumor biopsies.
III. Determine the toxicity of this drug.
OUTLINE:
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain
reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor
and by immunohistochemistry for pSrc expression.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
We will summarize the performance of the experimental therapy by computing the proportion of patients alive and progression free at 12 weeks and corresponding 95% posterior credible interval, both for the entire set of patients and separately by mutation status.
Time from start of treatment to time of progression or death, assessed at 12 weeks
No
Faye Johnson
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2009-00225
NCT00459342
March 2007
Name | Location |
---|---|
M D Anderson Cancer Center | Houston, Texas 77030 |