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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00750178
Enrollment
30
Registered
2008-09-10
Start date
2004-11-01
Completion date
2005-11-01
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Advanced

Brief summary

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

Interventions

DRUGvorinostat (MK0683 )

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

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety, tolerability, and PK of MK068328 Days

Secondary

MeasureTime frame
Urinary excretion of MK068328 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026