Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP) (NCT05552755) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluate REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)
United States67 participantsStarted 2023-07-10
Plain-language summary
This is a multicenter, two-part trial in participants with FAP.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female and ≥ 18 years of age
. Have provided written informed consent to participate in the study
. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site.
. Genetic diagnosis of FAP with APC gene mutation (Part 2 only).
. Has undergone colectomy or subtotal colectomy
. Spigelman Classification Stage II or higher.
. Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopies performed at Screening and while on study
. Have no significant cardiovascular abnormalities at Screening:
Exclusion criteria
. Has any clinically significant laboratory abnormality, medical or psychiatric illness which, in the opinion of the Investigator, could interfere with the conduct or interpretation of the study or put the participant at risk.
. Has had prior pelvic irradiation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881
Timeframe: Day 1 through Day 43
2
Part 1: Time to Reach Cmax (Tmax) of REC-4881
Timeframe: Day 1 through Day 43
3
Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881
Timeframe: Day 1 through Day 43
4
Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Day 1 through up to Week 37
5
Part 2: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: First 28 days of treatment
6
Part 2: Number of Participants Who Discontinued Treatment
Timeframe: Day 1 through up to Week 37
7
Part 2: Number of Participants With Dose Modification Due to Toxicity
. Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules.
. Has received treatment with other investigational agents within the 4 weeks prior to Study Day 1 or a period during which the investigational agent has not been cleared from the body (that is, at least a period of 5 half-lives, if known), whichever is longer.
. Treatment with other FAP-directed drug therapy (such as off-label use of Balsalazide) within 8 weeks of screening endoscopy (Part 2 only) or had a Whipple procedure.
. Is currently under treatment for desmoid tumors.
. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
. Use of strong cytochrome P3A (CYP3A) inhibitors or inducers prior to Study Day 1
8
Part 2: Percent Change From Baseline in Polyp Burden