A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer
Information source: Merck
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Cancer Relapsed; Advanced Cancer Refractory
Intervention: vorinostat (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval
in patients with relapsed or refractory advanced cancer.
Clinical Details
Official title: A Randomized, Partially-Blind, Placebo-Controlled, 2-Period Crossover Study to Assess the Effects of a Single Dose of Vorinostat on the QTc Interval in Patients With Advanced Cancer
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effect of a single dose of MK0683 (vorinostat) on the QTc interval.
Secondary outcome: To evaluate the safety and tolerability of a single dose of MK0683 (vorinostat).
Detailed description:
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression
or intolerable toxicity is reached
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has a histologically-confirmed metastatic or locally advanced solid tumor that
has failed to respond to standard therapy, progressed despite standard therapy or for
which standard therapy does not exist
- Patient has life expectancy of greater than 3 months
- Patient is able to swallow capsules
Exclusion Criteria:
- Patient has had chemotherapy, radiotherapy or biological therapy 2 weeks prior to
taking study drug.
- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of signing informed consent
- Patient has active CNS metastases and/or carcinomatous meningitis
- Patient has primary central nervous system tumor
- Patient has a history of drug or alcohol abuse
- Patient has Hepatitis B or C
- Patient is HIV positive
- Patient has active infection or has received intravenous antibiotics, antiviral or
antifungal agents 2 weeks before taking study drug
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Tampa, Florida 33612, United States; Recruiting
Call for Information, New Brunswick, New Jersey 08901-0000, United States; Recruiting
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: June 2007
Last updated: August 6, 2008
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