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REC-4881 for Familial Adenomatous Polyposis (TUPELO Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Recursion Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 43 days (part 1)
Awards & highlights
TUPELO Trial Summary
This trial will test a new drug to treat Familial Adenomatous Polyposis, a genetic disorder that causes many benign tumors. The study will compare the new drug to a placebo to see if it is effective and safe.
Who is the study for?
Adults over 18 with Familial Adenomatous Polyposis (FAP) who've had a colectomy can join this trial. They must not use strong CYP3A affecting drugs, NSAIDs (except low-dose aspirin), or have had recent cancer treatments. Those with certain GI diseases or difficulty swallowing pills are excluded.Check my eligibility
What is being tested?
The study tests REC-4881 against a placebo in people with FAP to see if it's effective and safe. It's conducted at multiple centers and includes two parts, focusing on patients who've undergone colon surgery due to their condition.See study design
What are the potential side effects?
Potential side effects of REC-4881 aren't specified here but could include typical drug reactions like stomach issues, fatigue, allergic responses, or interactions with other medications.
TUPELO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 43 days (part 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 days (part 1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate totality of data to determine the Recommended Phase 2 Dose (RP2D)
Percent change from baseline in polyp burden
Secondary outcome measures
Assess the effect of REC-4881 on polyp number, histological grade and disease score
Assess the pharmacodynamic (PD) effect of REC-4881, and correlation between PD and clinical outcome
Characterize plasma pharmacokinetic (PK) parameters of REC-4881
+1 moreTUPELO Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: REC-4881 8mg (Part 2)Experimental Treatment1 Intervention
Participants will receive REC-4881 8mg PO dosed once daily
Group II: REC-4881 4mg (Part 2)Experimental Treatment1 Intervention
Participants will receive REC-4881 4mg PO dosed once daily
Group III: REC-4881 4mg (Part 1)Experimental Treatment1 Intervention
Participants will receive REC-4881 4mg PO dosed once daily
Group IV: REC-4881 12mg (Part 2)Experimental Treatment1 Intervention
Participants will receive REC-4881 12mg PO dosed once daily
Group V: Placebo (Part 1)Placebo Group1 Intervention
Participants will receive placebo PO dosed once daily
Find a Location
Who is running the clinical trial?
Recursion Pharmaceuticals Inc.Lead Sponsor
3 Previous Clinical Trials
214 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for desmoid tumors.I haven't taken any FAP-targeted drugs in the last 8 weeks.I do not have active HIV, hepatitis B, or hepatitis C infections.I have not used strong CYP3A inhibitors or inducers before the study starts.I am 55 years old or older.I have pancreatitis caused by a blocked pancreatic duct.I have an active gallbladder condition.I am currently being treated for an infection.My blood counts are normal.My liver function is normal.My kidney function is normal.I am willing to stop taking NSAIDs before the study starts.I have had major surgery before the start of the study.I have a severe health condition that is not under control.I have not taken strong BCRP or MRP2 inhibitors before the study starts.My heart health is generally good, with no major issues.I haven't had major heart issues like a heart attack or unstable blood pressure in the last 6 months.I have FAP due to an APC gene mutation.I have a large polyp that cannot be fully removed.My cancer was found in my stomach, duodenum, or colon during an endoscopy.I don't have any major health or mental health issues.I have been treated with a MEK inhibitor before.I have a stomach condition or recent surgery that may affect how I absorb pills.I have a current or new eye problem.I am a woman and my pregnancy test before the study starts is negative.I have used omega-3 fatty acids or oral corticosteroids before starting the study.I have had surgery to remove all or part of my colon.I have FAP affecting my duodenum or lower digestive tract.I have received radiation treatment in the pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: REC-4881 4mg (Part 2)
- Group 2: REC-4881 4mg (Part 1)
- Group 3: REC-4881 8mg (Part 2)
- Group 4: Placebo (Part 1)
- Group 5: REC-4881 12mg (Part 2)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the limit of participants in this experiment?
"Affirmative. According to the clinicaltrials.gov website, this experiment is still in its recruitment phase. The trial was first made available on September 1st 2022 and has since been modified by researchers as recently as September 27th of that same year. A total of 171 participants will be accepted between one medical centre."
Answered by AI
What sort of safety hazards have been observed with REC-4881 12mg?
"Due to its Phase 2 nature, there is some evidence regarding REC-4881 12mg's safety but none surrounding efficacy. Thus, our organisation at Power has assigned it a rating of 2 on the 1 - 3 scale."
Answered by AI
Is it still possible to join this clinical research endeavor?
"Affirmative. Clinicaltrials.gov indicates that this medical study, which was originally posted on September 1st 2022, is actively recruiting individuals for participation. 171 volunteers are required from a single site to complete the trial."
Answered by AI
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