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NCT00251433 · ClinicalTrials.gov registry record · Phase 1

GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
53
Enrollment target

NCT00251433 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 53 participants.

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The verdict

NCT00251433, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
53 participants
Enrollment target

Study Summary

This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

Interventions

  • DRUG lapatinib, docetaxel, trastuzumab

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2005-09-26
Est. Completion 2022-06-22
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00251433

The ClinicalTrials.gov registry entry for NCT00251433 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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

NCT00251433 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00251433 about?

NCT00251433 is a clinical study titled "GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer". This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together. Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three dr...

What is the current status of trial NCT00251433?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2005-09-26. Estimated completion is 2022-06-22.

What interventions are being tested in trial NCT00251433?

The interventions under investigation include: lapatinib, docetaxel, trastuzumab (DRUG).

Who is sponsoring clinical trial NCT00251433?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.