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NCT02139397 · ClinicalTrials.gov registry record · Phase 1
Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma
A Phase 1 study of Neuroblastoma Recurrent, sponsored by Giselle Sholler.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 6
- Study locations
NCT02139397 is a Phase 1 study of Neuroblastoma Recurrent that has completed, run by Giselle Sholler. The registered enrollment target is 16 participants. The trial reports 6 study locations across 6 states.
The verdict
NCT02139397, a Phase 1 study of Neuroblastoma Recurrent, has completed, sponsored by Giselle Sholler.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the safety and tolerability of DFMO in combination with bortezomib as well as the tumors response to this study drug.
Conditions Studied
Interventions
- DRUG DFMO
- DRUG Bortezomib
Study Locations (6)
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Hospital - Hartford
Florida
- Arnold Palmer Hospital for Children- MD Anderson - Orlando
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-06-06 |
| Est. Completion | 2024-01-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02139397
The ClinicalTrials.gov registry entry for NCT02139397 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neuroblastoma Recurrent appearing as the primary indexed condition, and to 2 interventions - of which DFMO is the first listed.
NCT02139397 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Arkansas, Connecticut, Florida.
Frequently Asked Questions
What is clinical trial NCT02139397 about?
NCT02139397 is a clinical study titled "Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma". The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the saf...
What is the current status of trial NCT02139397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-06-06. Estimated completion is 2024-01-19.
What conditions does trial NCT02139397 study?
This clinical trial studies the following conditions: Neuroblastoma Recurrent.
What interventions are being tested in trial NCT02139397?
The interventions under investigation include: DFMO (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT02139397?
This trial is sponsored by Giselle Sholler, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02139397 being conducted?
This trial has 6 study locations across Arkansas, Connecticut, Florida, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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