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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 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.

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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.

Conditions Studied

Solid Tumor

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

FieldValue
Enrollment Target 76 participants
Start Date 2008-10
Est. Completion 2009-12
Phase Phase 2

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

102 total trials

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What the Registry Record Tells You About NCT00786838

The ClinicalTrials.gov registry entry for NCT00786838 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (66% lower). The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.