Clinical trial NCT00632931: A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer (0683-070)(COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer Relapsed
Advanced Cancer Refractory
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change From Baseline in QTcF at 0.5 Hours
timeFrame: Baseline and 0.5 hours
measure: Change From Baseline in QTcF at 1 Hour
timeFrame: Baseline and 1 hour
measure: Change From Baseline in QTcF at 2 Hours
timeFrame: Baseline and 2 hours
measure: Change From Baseline in QTcF at 3 Hours
timeFrame: Baseline and 3 hours
measure: Change From Baseline in QTcF at 4 Hours
timeFrame: Baseline and 4 hours
measure: Change From Baseline in QTcF at 8 Hours
timeFrame: Baseline and 8 hours
measure: Change From Baseline in QTcF at 12 Hours
timeFrame: Baseline and 12 hours
measure: Change From Baseline in QTcF at 24 Hours
timeFrame: Baseline and 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Munster PN, Rubin EH, Van Belle S, Friedman E, Patterson JK, Van Dyck K, Li X, Comisar W, Chodakewitz JA, Wagner JA, Iwamoto M. A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. Clin Cancer Res. 2009 Nov 15;15(22):7077-84. doi: 10.1158/1078-0432.CCR-09-1214. Epub 2009 Nov 3.