Last reviewed · How we verify
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
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2007-07 |
| Completion | 2009-04 |
Conditions
- Advanced Cancer Relapsed
- Advanced Cancer Refractory
Interventions
- vorinostat
- Comparator: placebo (unspecified)
Primary outcomes
- Change From Baseline in QTcF at 0.5 Hours — 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. - Change From Baseline in QTcF at 1 Hour — 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. - Change From Baseline in QTcF at 2 Hours — 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. - Change From Baseline in QTcF at 3 Hours — 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. - Change From Baseline in QTcF at 4 Hours — 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. - Change From Baseline in QTcF at 8 Hours — 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.