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

Phase 1

Completed

• Conditions: Cancer, Advanced
• Interventions: Drug: vorinostat (MK0683 )

• Registration Number: NCT00750178
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-01
• Primary Completion: 2005-08-01
• Study Completion: 2005-11-01
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years or older
• Must agree to consume high fat meal and agree to fasting conditions
• Limit alcohol consumption

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	vorinostat (MK0683 )	MK0683

Primary Outcome Measures

Name	Time	Method
Safety, tolerability, and PK of MK0683	28 Days

Secondary Outcome Measures

Name	Time	Method
Urinary excretion of MK0683	28 days