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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: Clinical Trial Phase 2 study, sponsored by Julie E. Bauman, MD, MPH.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) + number of patients that experience Stable Disease (SD) / total evaluable patients.
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 |
Why NCT01051791 stopped before completion
NCT01051791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Everolimus 10mg daily is the first listed.
NCT01051791 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01051791's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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