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NCT00422877 · ClinicalTrials.gov registry record · Phase 2

Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract

A Phase 2 study, sponsored by American Regent.

Terminated
Registry status
Phase 2
Development phase
13
Enrollment target

NCT00422877: Clinical Trial Phase 2 study, sponsored by American Regent.

NCT00422877 is a Phase 2 study that was terminated before completion, run by American Regent. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00422877, a Phase 2 study, was terminated before completion, sponsored by American Regent.

TERMINATED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study Summary

To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with primary liver cancer being treated with weekly Taxoprexin® Injection. To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.

Primary Outcome

Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target lesions determined

Interventions

  • DRUG Taxoprexin

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2007-01
Est. Completion 2008-03
Phase Phase 2
American Regent

34 total trials

Why NCT00422877 stopped before completion

NCT00422877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

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

NCT00422877 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00422877 about?

NCT00422877 is a clinical study titled "Taxoprexin® Treatment for Advanced Primary Cancers of the Liver, Gallbladder or Biliary Tract". To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment fail...

What is the current status of trial NCT00422877?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2007-01. Estimated completion is 2008-03.

What interventions are being tested in trial NCT00422877?

The interventions under investigation include: Taxoprexin (DRUG).

Who is sponsoring clinical trial NCT00422877?

This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00422877's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 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 NCT00422877, the US trial registry maintained by the National Library of Medicine. NCT00422877 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.