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NCT00786838 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram
A Phase 2 study of Solid Tumor, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 17
- Study locations
NCT00786838: Completed Phase 2 study of Solid Tumor, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00786838 is a Phase 2 study of Solid Tumor that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 76 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (66% lower). The trial reports 17 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00786838, a Phase 2 study of Solid Tumor, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trabectedin
Study Locations (17)
Other
- - Brussels
- - Edegem
- - Wilrijk
- - Lyon
- - Marseille
- - Montpellier
- - Villejuif
- - Bengaluru
- - Pune
- - Moscow
- - Saint Petersburg
- - Seoul
- - PAU de Sanchinarro
Florida
- - Miami
North Carolina
- - Charlotte
Pennsylvania
- - Philadelphia
Washington
- - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00786838 record still lists
NCT00786838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00786838 lists 17 locations in 5 states (Other, Florida, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00786838 about?
NCT00786838 is a clinical study titled "A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram". 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.
What is the current status of trial NCT00786838?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2008-10. Estimated completion is 2009-12.
What conditions does trial NCT00786838 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT00786838?
The interventions under investigation include: Placebo (DRUG), Trabectedin (DRUG).
Who is sponsoring clinical trial NCT00786838?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00786838 being conducted?
This trial has 17 study locations across Florida, North Carolina, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00786838's enrollment target sits among peer trials
76 101st of 196 higher than 96 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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