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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00750178
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.

Condition or disease Intervention/treatment Phase
Cancer, Advanced Drug: vorinostat (MK0683 ) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer
Actual Study Start Date : November 1, 2004
Primary Completion Date : August 1, 2005
Study Completion Date : November 1, 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
MK0683
Drug: vorinostat (MK0683 )

Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28

Total treatment period is 28 days

Other Name: Zolinza


Outcome Measures

Primary Outcome Measures :
  1. Safety, tolerability, and PK of MK0683 [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Urinary excretion of MK0683 [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750178


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Study Data/Documents: CSR Synopsis Links  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00750178     History of Changes
Other Study ID Numbers: 0683-008
MK0683-008
2008_544
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action