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NCT01338857 · ClinicalTrials.gov registry record · Phase 2
Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01338857: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.
NCT01338857 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338857, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors (low-grade astrocytomas) in children and adults. Previous research has given us a better understanding of this type of tumor by studying the genetic "make-up" of LGAs. From this research, the investigators found that a drug called sorafenib may stop the growth of tumor cells by blocking some of the molecules needed for cell growth and by blocking blood flow to the tumor. This trial is studying how well sorafenib works in treating patients with LGAs, and how the effects relate to the specific genetic "make-up" of your particular tumor. This testing of your tumor's genetic make-up is optional and requires available tumor tissue for testing. In summary, the aims of this study are: To see if sorafenib can shrink LGAs; how well sorafenib is tolerated in patients with LGAs; and, how the effects of sorafenib relate to the genetic make-up of individual LGAs (Optional Study)
Primary Outcome
To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas.
Interventions
- DRUG Sorafenib (Nexavar)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
Why NCT01338857 stopped before completion
NCT01338857 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib (Nexavar) is the first listed.
NCT01338857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01338857 about?
NCT01338857 is a clinical study titled "Sorafenib in Children and Young Adults With Recurrent or Progressive Low-Grade Astrocytomas". The purpose of this study is to determine if a drug called sorafenib can shrink LGA tumors (low-grade astrocytomas) in children and adults. Previous research has given us a better understanding of this type of tumor by studying the genetic "make-up" of LGAs. From this research, the investigators fou...
What is the current status of trial NCT01338857?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-04. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01338857?
The interventions under investigation include: Sorafenib (Nexavar) (DRUG).
Who is sponsoring clinical trial NCT01338857?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01338857's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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