A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)
April 5, 2017 updated by: Merck Sharp & Dohme LLC
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
MK0683
|
Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28 Total treatment period is 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety, tolerability, and PK of MK0683
Time Frame: 28 Days
|
28 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Urinary excretion of MK0683
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 8, 2008
First Submitted That Met QC Criteria
September 9, 2008
First Posted (Estimate)
September 10, 2008
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0683-008
- MK0683-008
- 2008_544
Plan for Individual participant data (IPD)
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.