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NCT00251095 · ClinicalTrials.gov registry record · Phase 3

Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

A Phase 3 study, sponsored by Achieve Life Sciences.

Terminated
Registry status
Phase 3
Development phase
821
Enrollment target

NCT00251095: Clinical Trial Phase 3 study, sponsored by Achieve Life Sciences.

NCT00251095 is a Phase 3 study that was terminated before completion, run by Achieve Life Sciences. The registered enrollment target is 821 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00251095, a Phase 3 study, was terminated before completion, sponsored by Achieve Life Sciences.

TERMINATED
Registry status
Phase 3
Development phase
821 participants
Enrollment target

Study Summary

The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.

Interventions

  • DRUG Taxol
  • DRUG TOCOSOL Paclitaxel

Trial Details

FieldValue
Enrollment Target 821 participants
Start Date 2005-09
Est. Completion 2007-09
Phase Phase 3
Achieve Life Sciences

17 total trials

Why NCT00251095 stopped before completion

NCT00251095 is an interventional study that assigns participants to a tested intervention. The registered 821 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Taxol is the first listed.

NCT00251095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00251095 about?

NCT00251095 is a clinical study titled "Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer". The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCO...

What is the current status of trial NCT00251095?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 821 participants. The study started on 2005-09. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00251095?

The interventions under investigation include: Taxol (DRUG), TOCOSOL Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT00251095?

This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00251095's enrollment target sits among peer trials

821 404th of 2000 higher than 1,597 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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Source: ClinicalTrials.gov NCT00251095, the US trial registry maintained by the National Library of Medicine. NCT00251095 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.