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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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00750178
First received: September 8, 2008
Last updated: April 5, 2017
Last verified: April 2017
  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 1

Study Type: Interventional
Study Design: 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

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
Actual Study Start Date: November 1, 2004
Study Completion Date: November 1, 2005
Primary Completion Date: August 1, 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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 ClinicalTrials.gov identifier: 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
Study First Received: September 8, 2008
Last Updated: April 5, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017