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NCT01158651 · ClinicalTrials.gov registry record · Phase 2
Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01158651: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT01158651 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01158651, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas in children with Neurofibromatosis type 1 (NF1). Additionally, the safety of RAD001 will be studied. The study drug, RAD001, is a drug that may act directly on tumor cells by preventing tumor cell growth and development. RAD001 has been studied in participants with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Information from these research studies suggests that RAD001 may help to shrink or slow the growth of low-grade gliomas. In this research study, the investigators are looking to see the response of RAD001 in children with low-grade gliomas and NF1 that have either not responded to treatment or have come back after treatment. We are also looking for the highest dose of RAD001 that can be given safely in this patient population.
Primary Outcome
Outcome is 2D MRI target tumor volume compared to baseline volume. Success criteria is volume less than 80% of baseline.
Interventions
- DRUG RAD001 (Everolimus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-07-10 |
| Est. Completion | 2017-10-26 |
| Phase | Phase 2 |
What the finished NCT01158651 record still lists
NCT01158651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which RAD001 (Everolimus) is the first listed.
NCT01158651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01158651 about?
NCT01158651 is a clinical study titled "Everolimus for Children With NF1 Chemotherapy-Refractory Radiographic Progressive Low Grade Gliomas". The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas in children with Neurofibromatosis type 1 (NF1). Additionally, the safety of RAD001 will be studied. The study drug, RAD001, is a drug that may act directly on tumor cells by p...
What is the current status of trial NCT01158651?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2010-07-10. Estimated completion is 2017-10-26.
What interventions are being tested in trial NCT01158651?
The interventions under investigation include: RAD001 (Everolimus) (DRUG).
Who is sponsoring clinical trial NCT01158651?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01158651's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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