RECRUITING

Evaluate REC-4881 in Patients With FAP

Conditions

Familial Adenomatous Polyposis FAP APC mutation adenomatous polyposis coli desmoid disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis (FAP).

Official Title

A Phase 1b-2, Multicenter, Trial To Evaluate The Efficacy, Safety, Pharmacokintetics, And Pharmacodynamics Of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)

Quick Facts

Study Start:2023-07-10

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05552755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female and ≥ 55 years of age 2. Have provided written informed consent to participate in the study 3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site. 4. Genetic diagnosis of FAP with APC gene mutation (Part 2 only). 5. Has undergone colectomy or subtotal colectomy 6. No significant cardiovascular abnormalities 7. Left ventricular ejection fraction of \>50% as determined by echocardiogram 8. No significant hematopoietic abnormalities 9. No significant hepatic abnormalities 10. No significant renal abnormalities 11. Female participants must have a negative serum pregnancy test prior to Study Day 1 12. All participants must be willing to follow the contraceptive guidance in the protocol 13. Absence of gross blood in stool at Screening 14. Participant must be willing to discontinue use of non-steroidal anti-inflammatory agents (NSAIDs) prior to Study Day 1	1. No clinically significant laboratory abnormality, medical or psychiatric illness 2. Has had prior pelvic irradiation. 3. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881 4. Has received treatment with other investigational agents prior to Study Day 1 5. Treatment with other FAP-directed drug therapy within 8 weeks of screening endoscopy (Part 2 only). 6. Is currently under treatment for desmoid tumors. 7. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1 8. Use of strong CYP3A inhibitors or inducers prior to Study Day 1 9. History of an ongoing or newly diagnosed eye abnormality. 10. Cancer at screening endoscopy in GI tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only). 11. Has a large polyp (\>1 cm) not amenable to complete removal 12. Has active pancreatitis secondary to pancreatic duct obstruction 13. Has active gall bladder disease 14. Is pregnant, lactating or is planning to attempt to become pregnant during the study 15. Has had major surgery prior to Study Day 1 16. Has an active infection requiring systemic therapy. 17. Has known hypersensitivity to the study drug or its excipients. 18. History of alcohol or substance abuse. 19. Received treatment with another MEK inhibitor prior to Screening 20. Active or known HIV, hepatitis B or hepatitis C infections 21. Has a severe or uncontrolled medical condition 22. Use of strong BCRP or MRP2 inhibitors prior to Study Day 1 23. Has clinically significant cardiovascular disease within 6 months of Day 1 including myocardial infarction or unstable angina, cardiac arrhythmias, uncontrolled hypertension, pulmonary embolism, QTcF prolongation, Congestive heart failure, Myocarditis or clinically significant pericarditis

Inclusion Criteria

Exclusion Criteria

1. Male or female and ≥ 55 years of age
2. Have provided written informed consent to participate in the study
3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
4. Genetic diagnosis of FAP with APC gene mutation (Part 2 only).
5. Has undergone colectomy or subtotal colectomy
6. No significant cardiovascular abnormalities
7. Left ventricular ejection fraction of \>50% as determined by echocardiogram
8. No significant hematopoietic abnormalities
9. No significant hepatic abnormalities
10. No significant renal abnormalities
11. Female participants must have a negative serum pregnancy test prior to Study Day 1
12. All participants must be willing to follow the contraceptive guidance in the protocol
13. Absence of gross blood in stool at Screening
14. Participant must be willing to discontinue use of non-steroidal anti-inflammatory agents (NSAIDs) prior to Study Day 1

1. No clinically significant laboratory abnormality, medical or psychiatric illness
2. Has had prior pelvic irradiation.
3. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881
4. Has received treatment with other investigational agents prior to Study Day 1
5. Treatment with other FAP-directed drug therapy within 8 weeks of screening endoscopy (Part 2 only).
6. Is currently under treatment for desmoid tumors.
7. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
8. Use of strong CYP3A inhibitors or inducers prior to Study Day 1
9. History of an ongoing or newly diagnosed eye abnormality.
10. Cancer at screening endoscopy in GI tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only).
11. Has a large polyp (\>1 cm) not amenable to complete removal
12. Has active pancreatitis secondary to pancreatic duct obstruction
13. Has active gall bladder disease
14. Is pregnant, lactating or is planning to attempt to become pregnant during the study
15. Has had major surgery prior to Study Day 1
16. Has an active infection requiring systemic therapy.
17. Has known hypersensitivity to the study drug or its excipients.
18. History of alcohol or substance abuse.
19. Received treatment with another MEK inhibitor prior to Screening
20. Active or known HIV, hepatitis B or hepatitis C infections
21. Has a severe or uncontrolled medical condition
22. Use of strong BCRP or MRP2 inhibitors prior to Study Day 1
23. Has clinically significant cardiovascular disease within 6 months of Day 1 including myocardial infarction or unstable angina, cardiac arrhythmias, uncontrolled hypertension, pulmonary embolism, QTcF prolongation, Congestive heart failure, Myocarditis or clinically significant pericarditis

Contacts and Locations

Study Contact

Recursion Pharmaceuticals

CONTACT

385-374-1724

clinicaltrials@recursionpharma.com

Study Locations (Sites)

Del Sol Research Management

Tucson, Arizona, 85715

United States

Medical Associates Research Group

San Diego, California, 92123

United States

GI Pros

Naples, Florida, 34102

United States

Digestive and Liver Center of Florida

Orlando, Florida, 32825

United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150

United States

Tandem Clinical Research

Marrero, Louisiana, 70072

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Gastro One-8110 Walnut Rs

Cordova, Tennessee, 38108

United States

Vanderbilt Digestive Center

Nashville, Tennessee, 37232

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Huntsman Cancer Institute and University of Utah

Salt Lake City, Utah, 84112

United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Recursion Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-07-10

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

FAP
familial adenomatous polyposis
APC mutation
adenomatous polyposis coli
desmoid disease

Additional Relevant MeSH Terms

Familial Adenomatous Polyposis