Trial Title:
Evaluate REC-4881 in Patients With FAP
NCT ID:
NCT05552755
Condition:
Familial Adenomatous Polyposis
Conditions: Official terms:
Adenomatous Polyposis Coli
Conditions: Keywords:
FAP
familial adenomatous polyposis
APC mutation
adenomatous polyposis coli
desmoid disease
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
REC-4881
Description:
REC-4881 4mg capsules
Arm group label:
REC-4881 12mg (Part 2)
Arm group label:
REC-4881 4mg (Part 1)
Arm group label:
REC-4881 4mg (Part 2)
Arm group label:
REC-4881 8mg (Part 2)
Intervention type:
Drug
Intervention name:
Placebo
Description:
Placebo capsules
Arm group label:
Placebo (Part 1)
Summary:
This is a multicenter, two-part trial in participants with Familial Adenomatous Polyposis
(FAP).
Detailed description:
This is a Phase 1b/2, trial to evaluate efficacy, safety, pharmacokinetics and
pharmacodynamics of REC-4881 in participants with Familial Adenomatous Polyposis (FAP).
This two-part study will treat participants with phenotypic classical FAP with disease
involvement of the duodenum or the residual colon/rectum/pouch as the primary disease
site.
Part 1 of the study enrolled seven participants with FAP who are
post-colectomy/proctocolectomy. Participants were randomized to Placebo or REC-4881.
Part 2 of the study will treat participants with escalating dose levels of REC-4881
during the Dose Finding. Participates in Cohort Expansion will be treated with a dose(s)
to determine the RP2D.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
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
Gender:
All
Minimum age:
55 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Del Sol Research Management
Address:
City:
Tucson
Zip:
85715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anitza Garcia
Phone:
520-635-4515
Email:
anitzagarcia@delresearch.com
Investigator:
Last name:
Fadi Deeb, MD
Email:
Principal Investigator
Facility:
Name:
Medical Associates Research Group
Address:
City:
San Diego
Zip:
92123
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maria Lopez
Phone:
858-277-5678
Email:
maria.opez@marginc.com
Investigator:
Last name:
Cainan Foltz, MD
Email:
Principal Investigator
Facility:
Name:
GI Pros
Address:
City:
Naples
Zip:
34102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paula Allain
Phone:
239-649-1336
Email:
pallainresearch@gmail.com
Investigator:
Last name:
Raymond Phillips, MD
Email:
Principal Investigator
Facility:
Name:
Digestive and Liver Center of Florida
Address:
City:
Orlando
Zip:
32825
Country:
United States
Status:
Recruiting
Contact:
Last name:
Natasha Contreras
Phone:
407-956-7663
Email:
natasha.contreras@dlcfl.com
Investigator:
Last name:
Harinath Sheela, MD
Email:
Principal Investigator
Facility:
Name:
Gastroenterology Health Partners, PLLC
Address:
City:
New Albany
Zip:
47150
Country:
United States
Status:
Recruiting
Contact:
Last name:
Danielle Kenney
Phone:
210-649-9391
Email:
danielle.kenney@iterative.health
Investigator:
Last name:
Jonathan Obert, MD
Email:
Principal Investigator
Facility:
Name:
Tandem Clinical Research
Address:
City:
Marrero
Zip:
70072
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chad Bordelon
Phone:
504-934-8424
Email:
cbordelon@tandemclinicalresearch.com
Investigator:
Last name:
Gary Reiss, MD
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sohpia Caterina
Phone:
215-349-8222
Email:
sophia.caterina@pennmedicine.upenn.edu
Investigator:
Last name:
Bryson Katona, MD
Email:
Principal Investigator
Facility:
Name:
Gastro One-8110 Walnut Rs
Address:
City:
Cordova
Zip:
38108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christine Wigley
Phone:
901-755-9110
Email:
cwigley@gastro1.com
Investigator:
Last name:
Ziad Younes, MD
Email:
Principal Investigator
Facility:
Name:
Vanderbilt Digestive Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Casey Koza
Phone:
615-875-6642
Email:
casey.koza@vumc.org
Investigator:
Last name:
Reid Ness, MD
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Diane Weber
Phone:
713-563-5752
Email:
dweber@mdanderson.org
Investigator:
Last name:
Eduardo Vilar-Sanchez, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute and University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nathan Bybee
Phone:
801-646-4172
Phone ext:
64172
Email:
Nathan.Bybee@hci.utah.edu
Contact backup:
Last name:
Megan Keener
Phone:
(801) 585-6439
Email:
Megan.Keener@hci.utah.edu
Investigator:
Last name:
Jessica Stout, MD
Email:
Principal Investigator
Facility:
Name:
Benaroya Research Institute at Virginia Mason
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brooke Grubb
Phone:
206-287-6260
Email:
brooke.grubb900@vmfh.org
Contact backup:
Last name:
Emily Chesterfield
Email:
emily.chesterfield@vmfh.org
Investigator:
Last name:
Gautam Mankaney, MD
Email:
Principal Investigator
Start date:
July 10, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Recursion Pharmaceuticals Inc.
Agency class:
Industry
Source:
Recursion Pharmaceuticals Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05552755
