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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer Relapsed

Advanced Cancer Refractory

Treatments

Drug: vorinostat

Drug: Comparator: placebo (unspecified)

Study type

Interventional

Funder types

Industry

Identifiers

2008_515

0683-070

MK0683-070

Details and patient eligibility

About

A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

Full description

Merck Duration of Treatment : vorinostat; treatment will continue until disease progression or intolerable toxicity is reached

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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