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NCT02157103 · ClinicalTrials.gov registry record · Phase 2
A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma
A Phase 2 study of Glioblastoma, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 2
- Study locations
NCT02157103: Completed Phase 2 study of Glioblastoma, sponsored by Emory University.
NCT02157103 is a Phase 2 study of Glioblastoma that has completed, run by Emory University. The registered enrollment target is 3 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02157103, a Phase 2 study of Glioblastoma, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 2
- Study locations
Study Summary
STUDY BACKGROUND: This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA approved for the treatment of glioblastoma that gets worse after standard therapy. For glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see if bevacizumab works as well when it is given as a daily subcutaneous shot as it does when given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The dose of bevacizumab given on this study is in total slightly lower than the FDA approved dose for glioblastoma. STUDY DESCRIPTION: About 10 people will take part in the study. Participants or caregivers will be educated on injection and given prefilled syringes to take home. Participants or caregivers will administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the refrigerator. Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks, the follow up interval can be increased to every 6 weeks at the treating physician's discretion. Participants can keep taking the bevacizumab until: * Tests show that they are not benefiting from it, * The participant has a bad side effect related to study treatment, * The participant can no longer comply with study requirements, or * The participant or doctor feels it is no longer in the participant's best interest.
Primary Outcome
To describe MRI response regarding edema and enhancement of glioblastoma and radiation-related brain enhancement when treated with subcutaneous bevacizumab daily. The therapeutic benefit of bevacizumab as regards glioblastoma multiforme (GBM) is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in enhancement and reduction in edema. For purposes of this study, any reduction in enhancement/edema by 25% or more will be conside
Conditions Studied
Interventions
- DRUG Bevacizumab 25 mg in 1 ml subcutaneously daily
Study Locations (2)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Winship Cancer Institutute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-01 |
| Phase | Phase 2 |
What the finished NCT02157103 record still lists
NCT02157103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab 25 mg in 1 ml subcutaneously daily is the first listed.
NCT02157103 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02157103 about?
NCT02157103 is a clinical study titled "A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma". STUDY BACKGROUND: This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA approved for the treatment of glioblastoma that gets worse after standard therapy. For glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see if beva...
What is the current status of trial NCT02157103?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2014-01. Estimated completion is 2018-01.
What conditions does trial NCT02157103 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT02157103?
The interventions under investigation include: Bevacizumab 25 mg in 1 ml subcutaneously daily (DRUG).
Who is sponsoring clinical trial NCT02157103?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02157103 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02157103's enrollment target sits among peer trials
3 199th of 199 higher than 1 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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.
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