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NCT01325207 · ClinicalTrials.gov registry record · Phase 1
Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01325207 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 34 participants.
The verdict
NCT01325207, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid. Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.
Interventions
- RADIATION Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-08-01 |
| Est. Completion | 2019-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01325207
The ClinicalTrials.gov registry entry for NCT01325207 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trastuzumab is the first listed.
NCT01325207 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01325207 about?
NCT01325207 is a clinical study titled "Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer". The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the...
What is the current status of trial NCT01325207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-08-01. Estimated completion is 2019-01-20.
What interventions are being tested in trial NCT01325207?
The interventions under investigation include: Trastuzumab (RADIATION).
Who is sponsoring clinical trial NCT01325207?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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