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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Cancer, Advanced

Treatments: Drug: vorinostat (MK0683 )

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750178

0683-008

MK0683-008

2008_544

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

A

Experimental group

Description:

MK0683

Treatment:

Drug: vorinostat (MK0683 )