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NCT00105950 · ClinicalTrials.gov registry record · Phase 2

Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
126
Enrollment target

NCT00105950: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT00105950 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00105950, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
126 participants
Enrollment target

Study Summary

This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.

Interventions

  • DRUG lapatinib

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2005-03
Est. Completion 2010-05
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00105950 record still lists

NCT00105950 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT00105950 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00105950 about?

NCT00105950 is a clinical study titled "Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer". This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistoch...

What is the current status of trial NCT00105950?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2005-03. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00105950?

The interventions under investigation include: lapatinib (DRUG).

Who is sponsoring clinical trial NCT00105950?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00105950's enrollment target sits among peer trials

126 556th of 2000 higher than 1,443 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 NCT00105950, the US trial registry maintained by the National Library of Medicine. NCT00105950 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.