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NCT00113607 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 3
Development phase
672
Enrollment target

NCT00113607 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 672 participants.

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The verdict

NCT00113607, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 3
Development phase
672 participants
Enrollment target

Study Summary

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Interventions

  • DRUG Dexamethasone
  • DRUG Trabectedin
  • DRUG DOXIL

Trial Details

FieldValue
Enrollment Target 672 participants
Start Date 2005-04
Est. Completion 2010-11
Phase Phase 3

What the Registry Record Tells You About NCT00113607

The ClinicalTrials.gov registry entry for NCT00113607 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 672 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.

NCT00113607 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00113607 about?

NCT00113607 is a clinical study titled "An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer". The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

What is the current status of trial NCT00113607?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 672 participants. The study started on 2005-04. Estimated completion is 2010-11.

What interventions are being tested in trial NCT00113607?

The interventions under investigation include: Dexamethasone (DRUG), Trabectedin (DRUG), DOXIL (DRUG).

Who is sponsoring clinical trial NCT00113607?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

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.