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NCT00111787 · ClinicalTrials.gov registry record · Phase 2
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00111787 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 49 participants.
The verdict
NCT00111787, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
Interventions
- DRUG Paclitaxel
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2005-04-11 |
| Est. Completion | 2006-11-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00111787
The ClinicalTrials.gov registry entry for NCT00111787 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 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 2 interventions - of which Paclitaxel is the first listed.
NCT00111787 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00111787 about?
NCT00111787 is a clinical study titled "Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer". This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical ...
What is the current status of trial NCT00111787?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-04-11. Estimated completion is 2006-11-01.
What interventions are being tested in trial NCT00111787?
The interventions under investigation include: Paclitaxel (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00111787?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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