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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: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the time between randomization and disease progression or death.
Interventions
- DRUG Dexamethasone
- DRUG Trabectedin
- DRUG DOXIL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 672 participants |
| Start Date | 2005-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00113607 record still lists
NCT00113607 is an interventional study that assigns participants to a tested intervention. The registered 672 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT00113607 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113607's enrollment target sits among peer trials
672 544th of 2000 higher than 1,457 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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