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NCT02155920 · ClinicalTrials.gov registry record · Phase 2
Everolimus for Children With Recurrent or Progressive Ependymoma
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT02155920 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT02155920, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable and has very limited treatment options. The rationale for this study is based upon both pre-clinical and clinical considerations: Immunohistochemistry studies have demonstrated that 20 out of 23 (87%) pediatric ependymomas are immunoreactive for phosphorylated S6, a biomarker that often predicts response to mTOR pathway-targeted therapy. Furthermore, children with with multiply recurrent ependymomas have had objective and durable responses to the mTOR inhibitor, Sirolimus (Rapamune, Pfizer). As a result of this pre-clinical and clinical data, this study will further investigate the activity of an mTOR pathway inhibitor, Everolimus, against children with recurrent or progressive ependymomas. In this study, Everolimus will be administered at a dose and schedule that have previously been demonstrated as safe and effective in children. Children may take Everolimus for up to 2 years on this study, until tumor progression or unacceptable toxicity.
Interventions
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-02 |
| Est. Completion | 2023-07-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02155920
The ClinicalTrials.gov registry entry for NCT02155920 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Everolimus is the first listed.
NCT02155920 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02155920 about?
NCT02155920 is a clinical study titled "Everolimus for Children With Recurrent or Progressive Ependymoma". The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable and has very limited treatment options. The rationale for this study is based upon both pre-clinical and clinical c...
What is the current status of trial NCT02155920?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2015-02. Estimated completion is 2023-07-14.
What interventions are being tested in trial NCT02155920?
The interventions under investigation include: Everolimus (DRUG).
Who is sponsoring clinical trial NCT02155920?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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