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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 polyps and other changes in the polyps 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 polyps 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.