Testing the Safety And Action of the Investigational Drug REC-4881 in People With Familial Adenomatous Polyposis (FAP) (TUPELO Study)
Prevention
Prevention study for people with an APC mutation and FAP who have had colectomy surgery
Clinicaltrials.gov identifier:NCT05552755
Study Contact Information:
Contact: Recursion Pharmaceuticals
385-374-1724 or by email: [email protected]
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.
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.
Study Contact Information:
Contact: Recursion Pharmaceuticals
385-374-1724 or by email: [email protected]
Locations:
Michigan
City: Grand Rapids RECRUITING
Facility: Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
Contact Info:
[email protected]
6163913825
James Ogilvie, MD
Minnesota
City: Rochester RECRUITING
Facility: Mayo Clinic - Rochester
Contact Info:
[email protected]
5072842511
Lisa Boardman, MD
Missouri
City: St Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
[email protected]
314-362-2646
Paul Wise, MD
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
[email protected]
(215) 349-8222
Bryson Katona, MD
Tennessee
City: Nashville RECRUITING
Facility: Vanderbilt Digestive Center
Contact Info:
[email protected]
(615) 875-6642
Reid Ness, MD
Texas
City: Dallas RECRUITING
Facility: Genetic Cancer Prevention Clinic - UT Southwestern
Contact Info:
[email protected]
214-645-4955
Luke Engelking, MD
City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
[email protected]
(713) 563-5752
Eduardo Vilar-Sanchez, MD
Utah
City: Salt Lake City RECRUITING
Facility: Huntsman Cancer Institute and University of Utah
Contact Info:
[email protected]
(801) 646-4172
Jessica Stout, MD
Washington
City: Seattle RECRUITING
Facility: Benaroya Research Institute at Virginia Mason
Contact Info:
[email protected]
(206) 287-6260
[email protected]
Gautam Mankaney, MD
Prevention
Prevention study for people with an APC mutation and FAP who have had colectomy surgery
Clinicaltrials.gov identifier:NCT05552755
Study Contact Information:
Contact: Recursion Pharmaceuticals
385-374-1724 or by email: [email protected]