Status:
TERMINATED
A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have re...
Eligibility Criteria
Inclusion
- Males and females 18 years of age and older with a confirmed diagnosis of non-small-cell lung cancer (NSCLC) who have failed at least one prior treatment for NSCLC.
- Patients must have proven disease by CT scan or MRI.
- Patients must be at least 4 weeks from any chemotherapy for cancer or from any surgeries or from any treatment using an investigational drug.
- Patients must be 2 weeks out from radiation therapy.
- At screening the patient must have normal lab results and can not be pregnant.
- Women and men must agree to practice adequate birth control during the study.
- Patient has the ability to understand and sign the consent form.
Exclusion
- Patient had prior treatment with vorinostat or erlotinib.
- Patient has any of the following conditions: active infections including hepatitis B or C, unstable brain metastases, swallowing difficulties, heart problems, significant eye abnormalities, drug or alcohol abuse, mental illness or pregnancy.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00251589
Start Date
January 1 2006
End Date
October 1 2007
Last Update
March 6 2015
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