CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
vorinostat +1 moredrug
Likely dose
vorinostat 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00632931
NCT00632931Phase 1Completed

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 Sharp & Dohme LLC·interventional·Posted Mar 11, 2008·Updated Jul 30, 2015

In Brief

A Phase 1 clinical trial evaluating vorinostat and Comparator: placebo (unspecified) for Advanced Cancer Relapsed and Advanced Cancer Refractory. Completed, enrolled 25 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2008
Enrollment StartJul 1, 2007
Primary CompletionMay 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.3 years ago

Interventions

vorinostatdrug

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.

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).