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NCT01187901 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
A Phase 2 study of Adenomatous Polyposis Coli, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT01187901: Completed Phase 2 study of Adenomatous Polyposis Coli, sponsored by University of Utah.
NCT01187901 is a Phase 2 study of Adenomatous Polyposis Coli that has completed, run by University of Utah. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01187901, a Phase 2 study of Adenomatous Polyposis Coli, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.
Primary Outcome
A comparison between the Sulindac-erlotinib and Placebo arms of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).
Conditions Studied
Interventions
- DRUG Erlotinib
- DRUG Sulindac
- DRUG Placebo A
- DRUG Placebo B
Study Locations (1)
Utah
- Huntsman Cancer Institute - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01187901 record still lists
NCT01187901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Adenomatous Polyposis Coli appearing as the primary indexed condition, and to 4 interventions - of which Erlotinib is the first listed.
NCT01187901 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01187901 about?
NCT01187901 is a clinical study titled "A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients". The purpose of this study is to determine in a randomized, placebo-controlled, phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis (FAP) and attenuated FAP (AFAP) patients.
What is the current status of trial NCT01187901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2010-04. Estimated completion is 2014-07.
What conditions does trial NCT01187901 study?
This clinical trial studies the following conditions: Adenomatous Polyposis Coli.
What interventions are being tested in trial NCT01187901?
The interventions under investigation include: Erlotinib (DRUG), Sulindac (DRUG), Placebo A (DRUG), Placebo B (DRUG).
Who is sponsoring clinical trial NCT01187901?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01187901 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01187901's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 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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