Skip to main content
OpenTrials
Completed

NCT Number: NCT00632931

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Cancer Relapsed Advanced Cancer Refractory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vorinostat

Drug

A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.

Other names: MK0683, Zolinza®

Comparator: Placebo (Unspecified)

Drug

A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).

Primary outcomes

  1. Change From Baseline in QTcF at 0.5 Hours

    Time frame: Baseline and 0.5 hours

    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.

  2. Change From Baseline in QTcF at 1 Hour

    Time frame: Baseline and 1 hour

    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.

  3. Change From Baseline in QTcF at 2 Hours

    Time frame: Baseline and 2 hours

    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.

  4. Change From Baseline in QTcF at 3 Hours

    Time frame: Baseline and 3 hours

    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.

  5. Change From Baseline in QTcF at 4 Hours

    Time frame: Baseline and 4 hours

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

  6. Change From Baseline in QTcF at 8 Hours

    Time frame: Baseline and 8 hours

    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.

  7. Change From Baseline in QTcF at 12 Hours

    Time frame: Baseline and 12 hours

    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.

  8. Change From Baseline in QTcF at 24 Hours

    Time frame: Baseline and 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 11, 2008
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.