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

Clinicaltrials.gov identifier:
NCT05552755

Prevention
Prevention study for people with an APC mutation and FAP who have had colectomy surgery

Study Contact Information:

Contact: Recursion Pharmaceuticals        
385-374-1724  or by email: clinicaltrials@recursionpharma.com

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 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 and other changes in the and to measure any side effects of the drug. 

For more information, visit the TUPELO Study page. 

Arizona

City: Scottsdale RECRUITING
Facility: Mayo Clinic - Scottsdale
Contact Info:
silva.jose2@mayo.edu 4805742508

City: Tucson RECRUITING
Facility: Del Sol Research Management
Contact Info:
anitzagarcia@delresearch.com (520) 635-4515

California

City: San Diego RECRUITING
Facility: Medical Associates Research Group
Contact Info:
maria.opez@marginc.com (858) 277-5678

Florida

City: Naples RECRUITING
Facility: GI Pros
Contact Info:
rphillips212@comcast.net (239) 649-1336

City: Orlando RECRUITING
Facility: Digestive and Liver Center of Florida
Contact Info:
natasha.contreras@dlcfl.com (407) 956-7663

Indiana

City: New Albany RECRUITING
Facility: Gastroenterology Health Partners, PLLC
Contact Info:
brandy.daly@onegi.com (210) 649-9391

Louisiana

City: Marrero RECRUITING
Facility: Tandem Clinical Research
Contact Info:
jledet@tandemclinicalresearch.com (504) 934-8424

Michigan

City: Grand Rapids RECRUITING
Facility: Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
Contact Info:
rachel.gross@corewellhealth.org 6163913825

Minnesota

City: Rochester RECRUITING
Facility: Mayo Clinic - Rochester
Contact Info:
helgeson.lauren@mayo.edu 5072842511

Missouri

City: St. Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
asimabadic@wustl.edu 314-362-2646

Pennsylvania

City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
sophia.caterina@pennmedicine.upenn.edu (215) 349-8222

Tennessee

City: Cordova RECRUITING
Facility: Gastro One-8110 Walnut Rs
Contact Info:
geoffrey.craigie@onegi.com (901) 755-9110

City: Nashville RECRUITING
Facility: Vanderbilt Digestive Center
Contact Info:
casey.koza@vumc.org (615) 875-6642

Texas

City: Dallas RECRUITING
Facility: Genetic Cancer Prevention Clinic - UT Southwestern
Contact Info:
yaemi.cheng@utsouthwestern.edu 214-645-4955

City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
dweber@mdanderson.org (713) 563-5752

Utah

City: Salt Lake City RECRUITING
Facility: Huntsman Cancer Institute and University of Utah
Contact Info:
Tavia.Dutson@hci.utah.edu (801) 646-4172

Washington

City: Seattle RECRUITING
Facility: Benaroya Research Institute at Virginia Mason
Contact Info:
brooke.grubb900@vmfh.org (206) 287-6260
emily.chesterfield@vmfh.org

This Study is Open To:

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

  • have in their duodenum or remaining colon, rectum or pouch.
  • have tested positive for an  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. 

This Study is Not Open To:

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.