Overview

A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Vorinostat
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