Status:
TERMINATED
A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET...
Eligibility Criteria
Inclusion
- Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
- Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
- Has a measurable, positron emission tomography (PET) assessable lesion
- Adequate blood, liver, bone marrow and kidney functions
- Has not received any chemotherapy for at least 4 weeks prior to entry in this study
- Agrees to take adequate measures to prevent pregnancy.
Exclusion
- Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
- Patient has had treatment with investigational agents within the last 30 days.
- Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
- Patient has HIV, hepatitis B or hepatitis C infection.
- Patient is pregnant or lactating.
- Patient has allergy to any component of the study drug.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00126451
Start Date
December 1 2004
End Date
October 11 2005
Last Update
April 10 2017
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