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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 8, 2008
Last updated: August 18, 2015
Last verified: August 2015
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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

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
Experimental: A
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00750178

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00750178     History of Changes
Other Study ID Numbers: 0683-008  MK0683-008  2008_544 
Study First Received: September 8, 2008
Last Updated: August 18, 2015

Additional relevant MeSH terms:
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 24, 2017