A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer

This study has been completed.

First Received: September 8, 2008 Last Updated: September 9, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00750178

Purpose

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.

Condition	Intervention	Phase
Cancer, Advanced	Drug: vorinostat (MK0683 )	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 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer

Further study details as provided by Merck:

Primary Outcome Measures:

Safety, tolerability, and PK of MK0683 [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Urinary excretion of MK0683 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	November 2004
Study Completion Date:	November 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental MK0683	Drug: vorinostat (MK0683 ) Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28 Total treatment period is 28 days

Eligibility

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

Criteria

Inclusion Criteria:

Patients 18 years or older
Must agree to consume high fat meal and agree to fasting conditions
Limit alcohol consumption

Exclusion Criteria:

Patient has a history of drug or alcohol abuse within 5 years of start of study
Patient is known to have HIV
Patient has participated in another investigational study within 4 weeks of start of study
Patient cannot stop taking certain medications or herbal remedies
Patient will require immunologic, radiation, surgery, or chemotherapy during the study
Patient requires frequent blood transfusions
Female patient is pregnant or nursing
Patient has an active Hepatitis B or C infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750178

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_544, MK0683-008
Study First Received:	September 8, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750178 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Vorinostat

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vorinostat
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 May 07, 2009