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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer Relapsed, Advanced Cancer Refractory

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in QTcF at 0.5 Hours

Outcome Description:

The Fridericia correction of the QT interval (QTcF) was determined at each time point from five replicate measurements. The change from baseline in QTcF was calculated by subtracting the QTcF value at each timepoint from the QTcF baseline (predose) value.

Outcome Time Frame:

Baseline and 0.5 hours

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2008_515

NCT ID:

NCT00632931

Start Date:

June 2007

Completion Date:

April 2009

Related Keywords:

  • Advanced Cancer Relapsed
  • Advanced Cancer Refractory
  • Neoplasms

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