Status:
COMPLETED
A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Advanced Cancer Relapsed
Advanced Cancer Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00632931
Start Date
July 1 2007
End Date
April 1 2009
Last Update
July 30 2015
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