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NCT00634270 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00634270 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 58 participants.
The verdict
NCT00634270, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Treatment Overview This phase II study will evaluate the activity of sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas that have the potential to cause significant morbidity. The following disease strata will be studied: Stratum 1: Progressive plexiform neurofibroma(s) that have the potential to cause significant morbidity. The endpoint will be time to tumor progression based on volumetric tumor measurements. Stratum 2: Plexiform neurofibromas without documented radiographic progression at trial entry. The endpoint will be radiographic response. As of May 2009, Stratum 2 was closed to enrollment. Stratum 1 is active.
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00634270
The ClinicalTrials.gov registry entry for NCT00634270 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT00634270 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00634270 about?
NCT00634270 is a clinical study titled "A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas". Treatment Overview This phase II study will evaluate the activity of sirolimus in children and adults with NF1 and inoperable plexiform neurofibromas that have the potential to cause significant morbidity. The following disease strata will be studied: Stratum 1: Progressive plexiform neurofibroma(...
What is the current status of trial NCT00634270?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2008-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00634270?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00634270?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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