A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)
NCT ID: NCT00750178
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2004-11-01
2005-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
MK0683
vorinostat (MK0683 )
Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28
Total treatment period is 28 days
Interventions
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vorinostat (MK0683 )
Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28
Total treatment period is 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must agree to consume high fat meal and agree to fasting conditions
* Limit alcohol consumption
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Rubin EH, Agrawal NG, Friedman EJ, Scott P, Mazina KE, Sun L, Du L, Ricker JL, Frankel SR, Gottesdiener KM, Wagner JA, Iwamoto M. A study to determine the effects of food and multiple dosing on the pharmacokinetics of vorinostat given orally to patients with advanced cancer. Clin Cancer Res. 2006 Dec 1;12(23):7039-45. doi: 10.1158/1078-0432.CCR-06-1802.
Study Documents
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Document Type: CSR Synopsis Links
View DocumentOther Identifiers
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MK0683-008
Identifier Type: -
Identifier Source: secondary_id
2008_544
Identifier Type: -
Identifier Source: secondary_id
0683-008
Identifier Type: -
Identifier Source: org_study_id
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