A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00127127

Purpose

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in patients with solid tumors.

Condition	Intervention	Phase
Tumors	Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Suberoylanilide hydroxamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Clinical Study of MK0683 in Patients With Solid Tumors.

Further study details as provided by Merck:

Primary Outcome Measures:

Safety [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	June 2005
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1. level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day	Drug: vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) vorinostat; level 1: 100 mg BID 14-day, level 2: 200 mg BID 14-day, level 3: 400 mg QD 14 day, level 5: 500 mg QD 14-day

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically or cytologically diagnosed solid tumor; no standard therapy available or patient has failed to respond to standard therapy

Exclusion Criteria:

Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
Any uncontrolled concomitant illness
Are pregnant or breast-feeding
Serious drug or food allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127127

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_040, MK0683-029
Study First Received:	August 3, 2005
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00127127
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Merck:

Solid tumors

Study placed in the following topic categories:

Vorinostat

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009