CompletedPhase 2

A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients

United States92 participantsStarted 2010-04

Plain-language 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.

Who can participate

Age range18 Years – 69 Years

SexALL

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Exclusion criteria

✕. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia
✕. Severely impaired lung function
✕. Any active (acute or chronic) or uncontrolled infection/ disorders.
✕. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy
✕. Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
✕. anemia
✕. thrombocytopenia
✕. leucopenia

What they're measuring

Change in Duodenal Polyp Burden From Baseline to 6 Months

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT01187901

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2016-05-10

View on ClinicalTrials.gov More Adenomatous Polyposis Coli trials