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)

Phase 2

Terminated

• Conditions: Non-small-cell Lung Carcinoma; Breast Cancer; Colorectal Cancer

• Registration Number: NCT00126451
• Lead Sponsor: Merck Sharp & Dohme LLC

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-01
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-04
• Primary Completion: 2005-10-11
• Study Completion: 2005-10-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.

Secondary Outcome Measures

Name	Time	Method
Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days.