Status:
TERMINATED
Dasatinib in Advanced Squamous Cell Lung Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Squamous Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that...
Detailed Description
Dasatinib will be taken orally, daily in cycles of 28 days. On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following: * Medical history and...
Eligibility Criteria
Inclusion
- Stage III/B or IV squamous NSCLC
- Measurable disease
- Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
- ECOG performance status of 0 or 1
- Estimated life expectancy greater than 12 weeks
- Normal organ and marrow function
- Confirmed availability of archival pathology samples
- Agrees to discontinue St. Johns Wort
- Able to take medications by mouth
- Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug
Exclusion
- Pregnant or breast-feeding
- Chemotherapy or radiotherapy within 4 weeks prior to entering study
- Receiving any other investigational agents
- Known untreated or progressive brain metastases
- History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
- Taking medications known to be potent CYP3A4 inhibitors
- Currently taking H2 inhibitors or proton pump inhibitors
- Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
- HIV positive
- Clinically uncontrolled hypertension (blood pressure \> 160/110)
- Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
- Active and uncontrolled clinically significant infection
- Chronic gastrointestinal disease
- Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
- Supplemental oxygen required for current malignancy
- Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
- Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01491633
Start Date
September 1 2011
End Date
May 1 2013
Last Update
July 15 2014
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215