A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00126451

Purpose

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	Intervention	Phase
Breast Cancer Colorectal Cancer Non-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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Lung Cancer

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	42
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126451

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Vansteenkiste J, Cutsem EV, Dumez H, Chen C, Ricker JL, Randolph SS, Schöffski P. Early phase II trial of oral vorinostat in relapsed or refractory breast, colorectal, or non-small cell lung cancer. Invest New Drugs. 2008 Apr 19; [Epub ahead of print]

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_014, MK0683-011
Study First Received:	August 2, 2005
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00126451 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Rectal Diseases
Neoplasms by Site
Respiratory Tract Diseases
Sensory System Agents
Lung Neoplasms
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Breast Diseases
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Skin Diseases
Vorinostat
Breast Neoplasms
Enzyme Inhibitors
Intestinal Diseases
Protective Agents
Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010