At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 76 enrolled
Drug / intervention
Trabectedin +1 moredrug
Likely dose
Trabectedin 1.3 mg/m2from 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.
A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 6, 2008·Updated Apr 11, 2014
In Brief
A Phase 2 clinical trial evaluating Trabectedin and Placebo for Solid Tumor. Completed, enrolled 76 participants across 17 sites in 7 countries.
Detailed Summary
The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesBelgium, France, India, Russia, South Korea, Spain, United States
CollaboratorsPharmaMar
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedNov 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedNov 6, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.7 years ago
Interventions
Trabectedindrug
Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2.
Placebodrug
Participants will receive 3-hour placebo intravenous infusion on Day 1.