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

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0683 in patients with advanced cancer.

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Key information

Conditions

Cancer, Advanced Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vorinostat (MK0683 )

Drug

Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28

Total treatment period is 28 days

Other names: Zolinza

Primary outcomes

Safety, tolerability, and PK of MK0683

Time frame: 28 Days

Secondary outcomes

Urinary excretion of MK0683

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Sep 10, 2008
Registry last updated: Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed