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A Phase 2 Trial of Dasatinib in Patients With Lung Adenocarcinoma With Acquired Resistance to Erlotinib or Gefitinib
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.
OBJECTIVES: Primary * 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. Secondary * 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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
June 1, 2006
Primary Completion Date
September 1, 2011
Completion Date
September 1, 2011
Last Updated
January 22, 2016
22
ACTUAL participants
dasatinib
DRUG
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06305754
NCT07336732
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05692635