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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: Completed Phase 1 study, sponsored by Northwestern University.
NCT01325207 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients will be treated using a standard 3+3 dose-escalation design for cohorts 1 and 2. This will be followed by an accelerated phase I for cohorts 3 and 4, and then a standard 3 + 3 for the 5th cohort. In the accelerated phase (cohorts 3 and 4), 1 patient will be enrolled per cohort; if a toxicity is seen in that patient then the cohort would be expanded to 6 patients to allow for 1/6 patients per cohort to have a dose limiting toxicity (DLT) before dose escalation. Cohort 5 will enroll a tot
Interventions
- RADIATION Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-08-01 |
| Est. Completion | 2019-01-20 |
| Phase | Phase 1 |
What the finished NCT01325207 record still lists
NCT01325207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Trastuzumab is the first listed.
NCT01325207 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01325207's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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