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

About the Study

This study is looking at how safe and effective the research drug REC-4881 is for treating polyps in people with Familial Adenomatous Polyposis (FAP).

Participants will take the drug REC-4881 once daily by mouth. A participant's dose will depend on when they join the study. 

Participants will be followed closely for 16 weeks with bloodwork, screening and exams to look at effects of REC-4881 on the number of polyps and other changes in the polyps and to measure any side effects of the drug. 

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.