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NCT01051791 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of RAD001 Head and Neck Cancer
A Phase 2 study, sponsored by Julie E. Bauman, MD, MPH.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01051791 is a Phase 2 study that was terminated before completion, run by Julie E. Bauman, MD, MPH. The registered enrollment target is 13 participants.
The verdict
NCT01051791, a Phase 2 study, was terminated before completion, sponsored by Julie E. Bauman, MD, MPH.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
To carry out exploratory studies to determine if activity of this regimen correlates with tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate with activity of this regimen and provide exploratory insights in to the mechanism of this treatment approach. Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27 and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment, and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be submitted in place of the pre-treatment biopsy.
Interventions
- DRUG Everolimus 10mg daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-08-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01051791
The ClinicalTrials.gov registry entry for NCT01051791 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Julie E. Bauman, MD, MPH, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Everolimus 10mg daily is the first listed.
NCT01051791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01051791 about?
NCT01051791 is a clinical study titled "Phase II Study of RAD001 Head and Neck Cancer". To carry out exploratory studies to determine if activity of this regimen correlates with tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate with activity of this regimen and provide exploratory insights in to the mechanism of this treatment approach. Express...
What is the current status of trial NCT01051791?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2010-01. Estimated completion is 2016-08-05.
What interventions are being tested in trial NCT01051791?
The interventions under investigation include: Everolimus 10mg daily (DRUG).
Who is sponsoring clinical trial NCT01051791?
This trial is sponsored by Julie E. Bauman, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
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