NCT00750178

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

September 8, 2008

Last Update Submit

April 5, 2017

Conditions

Cancer, Advanced

Outcome Measures

Primary Outcomes (1)

  • Safety, tolerability, and PK of MK0683

    28 Days

Secondary Outcomes (1)

  • Urinary excretion of MK0683

    28 days

Study Arms (1)

A

EXPERIMENTAL

MK0683

Drug: vorinostat (MK0683 )

Interventions

vorinostat (MK0683 )DRUG

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

Also known as: Zolinza
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 with advanced cancer. Clin Cancer Res. 2006 Dec 1;12(23):7039-45. doi: 10.1158/1078-0432.CCR-06-1802.

    PMID: 17145826RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Vorinostat

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 10, 2008

Study Start

November 1, 2004

Primary Completion

August 1, 2005

Study Completion

November 1, 2005

Last Updated

April 7, 2017

Record last verified: 2017-04