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)

• Status: Terminated
• Trial end date: 2005-10-11
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Vorinostat

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.