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NCT01484041 · ClinicalTrials.gov registry record · Phase 1
Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer
A Phase 1 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01484041: Clinical Trial Phase 1 study, sponsored by Georgetown University.
NCT01484041 is a Phase 1 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484041, a Phase 1 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine how well these medications work together and/or if they have any side effects in patients with hormone-receptor positive metastatic breast cancer who have demonstrated progression of disease after first line hormonal therapy. This research is being done to determine if taking an already approved medicine (aromatase inhibitor) in combination with a new medication (dovitinib) results in better outcomes for patients with this disease. Both dovitinib and an aromatase inhibitor are pills that will be taken at home.
Primary Outcome
Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appear
Interventions
- DRUG Dovitinib
- DRUG Aromatase Inhibitors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-04 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
Why NCT01484041 stopped before completion
NCT01484041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Dovitinib is the first listed.
NCT01484041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484041 about?
NCT01484041 is a clinical study titled "Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer". This study is for women with confirmed hormone receptor positive HER-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine how well these medications work together and/or if they have any side effects in patients w...
What is the current status of trial NCT01484041?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-04. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01484041?
The interventions under investigation include: Dovitinib (DRUG), Aromatase Inhibitors (DRUG).
Who is sponsoring clinical trial NCT01484041?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01484041's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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