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)
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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 as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.
Condition or disease
Breast CancerColorectal CancerNon-small-cell Lung Carcinoma
Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)Drug: Duration of Treatment - During each treatment cycle, treatment is administered twice daily for 14 days, followed by 7 days of rest for a total of 10 cycles
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.