Testing the Safety And Action of the Investigational Drug REC-4881 in People With Familial Adenomatous Polyposis (FAP) (TUPELO Study)

The study is open to adults age 55 or older who have been diagnosed with classic FAP who:

• have polyps in their duodenum or remaining colon, rectum or pouch.
• have tested positive for an APC gene mutation.
• have had surgery to remove their colon (colectomy or subtotal colectomy). 
• have normal heart, liver, and kidney function no blood abnormalities.
• are not pregnant and are willing to use contraception to avoid getting pregnant.
• are willing to stop using non-steroidal anti-inflammatory drugs (NSAIDs) before starting the study. 

See clinicaltrials.gov for the full list of inclusion criteria. 

People cannot participate who: 

• have had prior radiation to their pelvis.
• have gastrointestinal disease or procedure that would keep them from absorbing the oral study medicine.
• are receiving treatment with other research agents or drugs used to treat FAP within 8 weeks of the screening endoscopy. 
• use of omega-3 fatty acids or steroids before starting the study. 
• have a history of or ongoing eye abnormality.
• receive a diagnosis of cancer during the screening endoscopy. 
• have a large polyp (more than a cm) that cannot be completely removed.
• have previously received treatment with a MEK inhibitor. 
• has active or known HIV, hepatitis B or hepatitis C infections.

See clinicaltrials.gov for the full list of exclusion criteria.