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]
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.
For more information, visit the TUPELO Study page.
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:
Arizona
City: Scottsdale RECRUITING
Facility: Mayo Clinic - Scottsdale
Contact Info:
[email protected]
4805742508
City: Tucson RECRUITING
Facility: Del Sol Research Management
Contact Info:
[email protected]
(520) 635-4515
California
City: San Diego RECRUITING
Facility: Medical Associates Research Group
Contact Info:
[email protected]
(858) 277-5678
Florida
City: Naples RECRUITING
Facility: GI Pros
Contact Info:
[email protected]
(239) 649-1336
City: Orlando RECRUITING
Facility: Digestive and Liver Center of Florida
Contact Info:
[email protected]
(407) 956-7663
Indiana
City: New Albany RECRUITING
Facility: Gastroenterology Health Partners, PLLC
Contact Info:
[email protected]
(210) 649-9391
Louisiana
City: Marrero RECRUITING
Facility: Tandem Clinical Research
Contact Info:
[email protected]
(504) 934-8424
Michigan
City: Grand Rapids RECRUITING
Facility: Corewell Health (Spectrum Health Hospitals Colorectal Cancer Multis)
Contact Info:
[email protected]
6163913825
Minnesota
City: Rochester RECRUITING
Facility: Mayo Clinic - Rochester
Contact Info:
[email protected]
5072842511
Missouri
City: St. Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
[email protected]
314-362-2646
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
[email protected]
(215) 349-8222
Tennessee
City: Cordova RECRUITING
Facility: Gastro One-8110 Walnut Rs
Contact Info:
[email protected]
(901) 755-9110
City: Nashville RECRUITING
Facility: Vanderbilt Digestive Center
Contact Info:
[email protected]
(615) 875-6642
Texas
City: Dallas RECRUITING
Facility: Genetic Cancer Prevention Clinic - UT Southwestern
Contact Info:
[email protected]
214-645-4955
City: Houston RECRUITING
Facility: MD Anderson Cancer Center
Contact Info:
[email protected]
(713) 563-5752
Utah
City: Salt Lake City RECRUITING
Facility: Huntsman Cancer Institute and University of Utah
Contact Info:
[email protected]
(801) 646-4172
Washington
City: Seattle RECRUITING
Facility: Benaroya Research Institute at Virginia Mason
Contact Info:
[email protected]
(206) 287-6260
[email protected]