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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 126 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105950
The ClinicalTrials.gov registry entry for NCT00105950 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lapatinib is the first listed.
NCT00105950 reports 0 study locations.
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.
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