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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: Completed Phase 1 study of Neuroblastoma Recurrent, sponsored by Giselle Sholler.
NCT02139397 is a Phase 1 study of Neuroblastoma Recurrent that has completed, run by Giselle Sholler. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Phase I- To determine the safety and tolerability of DFMO in combination with bortezomib at 3 dose levels of DFMO: 1500mg/m2 twice daily, 2000mg/m2 twice daily, and 2500mg/m2 twice daily in subjects with relapsed or refractory neuroblastoma who receive one full cycle of this dose. Phase II- Study did not enroll to Phase II. Study completed at end of Phase I.
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 |
What the finished NCT02139397 record still lists
NCT02139397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT02139397's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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