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NCT00072670 · ClinicalTrials.gov registry record · Phase 2

A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer

A Phase 2 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 2
Development phase
59
Enrollment target

NCT00072670: Completed Phase 2 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

NCT00072670 is a Phase 2 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00072670, a Phase 2 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 2
Development phase
59 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.

Primary Outcome

The PSA response will be evaluated according to National Cancer Institute PSA Working Group criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline after the first dose of study drug, which would be subsequently confirmed by a measurement, that is, at least 4 or more weeks after initial documentation of PSA.

Interventions

  • DRUG Trabectedin

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2004-01
Est. Completion 2008-11
Phase Phase 2

What the finished NCT00072670 record still lists

NCT00072670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 1 intervention - of which Trabectedin is the first listed.

NCT00072670 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00072670 about?

NCT00072670 is a clinical study titled "A Phase 2 Study of Trabectedin (Yondelis) in Adult Male Participants With Advanced Prostate Cancer". The purpose of this study is to evaluate safety and efficacy of trabectedin (ET-743) in adult male participants with advanced metastatic (spread of cancer cells from one part of the body to another) prostate cancer.

What is the current status of trial NCT00072670?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2004-01. Estimated completion is 2008-11.

What interventions are being tested in trial NCT00072670?

The interventions under investigation include: Trabectedin (DRUG).

Who is sponsoring clinical trial NCT00072670?

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

How this trial's enrollment target compares

Where NCT00072670's enrollment target sits among peer trials

59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00072670, the US trial registry maintained by the National Library of Medicine. NCT00072670 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.