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

Cancer, Advanced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750178
• Other study ID #: 0683-008
• Secondary ID: MK0683-0082008_5
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2008
• Last updated: April 5, 2017
• Start date: November 1, 2004
• Est. completion date: November 1, 2005

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2005
• Est. primary completion date: August 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Advanced

Intervention

Drug:
• vorinostat (MK0683 )
Panel A: vorinostat 400 mg capsules once daily on Days 1, 5, 7-28 Total treatment period is 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 w — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability, and PK of MK0683		28 Days
Secondary	Urinary excretion of MK0683		28 days