A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib
- To determine the overall response rate (complete response and partial response) in
patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced
adenocarcinoma of the lung treated with dasatinib.
- To determine the progression-free survival and overall survival of patients treated
with this drug.
- To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas
treated with this drug.
- To determine the progression-free survival and overall survival of patients with EGFR
T790M lung adenocarcinomas treated with this drug.
- To determine the toxicity profile of dasatinib in these patients.
OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy,
patients receive oral dasatinib twice daily. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of confirmed tumor responses ( complete or partial response) as measured by RECIST
Vincent A. Miller, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|