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NCT00957853 · ClinicalTrials.gov registry record · Phase 2
Preoperative Treatment With Cetuximab and/or IMC-A12
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00957853: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00957853 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957853, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied.
Primary Outcome
An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three tre
Interventions
- DRUG Cetuximab
- DRUG IMC-A12
- PROCEDURE Surgical tumor resection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-10-17 |
| Est. Completion | 2018-08-15 |
| Phase | Phase 2 |
What the finished NCT00957853 record still lists
NCT00957853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT00957853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957853 about?
NCT00957853 is a clinical study titled "Preoperative Treatment With Cetuximab and/or IMC-A12". The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a ...
What is the current status of trial NCT00957853?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2011-10-17. Estimated completion is 2018-08-15.
What interventions are being tested in trial NCT00957853?
The interventions under investigation include: Cetuximab (DRUG), IMC-A12 (DRUG), Surgical tumor resection (PROCEDURE).
Who is sponsoring clinical trial NCT00957853?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00957853's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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