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 22, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety Study
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 ] [ 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
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
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
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:
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 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014