What side effects are associated with this type of intervention?

Common treatments for Adenomatous Polyposis, such as aspirin and NSAIDs, are associated with side effects including peptic ulcers, bleeding events, cardiovascular risks, and gastrointestinal issues. Other reported adverse events in similar treatments include alopecia, wound infection, sensory symptoms, systemic lupus, vasculitis, and severe injection site reactions. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

There is no specific information provided about prior FDA approvals for the treatment of Adenomatous Polyposis in the given context. Generally, treatments for Familial Adenomatous Polyposis (FAP) include nonsteroidal anti-inflammatory drugs (NSAIDs) like sulindac and celecoxib, which have been studied for their potential to reduce polyp formation. Surgical options, such as colectomy, are also common for managing the condition. The trial mentioned appears to be investigating a new treatment, but further details are not provided.

What other types of research exist?

Promising novel alternatives for Adenomatous Polyposis patients in 2024 include the investigational drug REC-4881 and colon capsule endoscopy for diagnostic purposes.

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Placebo

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 16 weeks (part 2)

Summary

This trial is testing a new drug called REC-4881 in people with Familial Adenomatous Polyposis (FAP). The goal is to see if the drug can reduce or slow the growth of polyps in their intestines, making the condition easier to manage and potentially avoiding more surgeries.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks (part 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks (part 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks (part 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate totality of data to determine the Recommended Phase 2 Dose (RP2D)

Incidence of Treatment-Emergent Adverse Events

Percent change from baseline in polyp burden

Secondary study objectives

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

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Adenomatous Polyposis, especially Familial Adenomatous Polyposis (FAP), include NSAIDs like aspirin and sulindac, which work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2) to reduce polyp formation. Surgical options such as colectomy are also frequently used to remove polyps and prevent colorectal cancer. These treatments are vital for FAP patients as they help manage polyp growth and significantly reduce the risk of progression to colorectal cancer.

Feasibility of a novel low-volume and sodium phosphate-free bowel preparation regimen for colon capsule endoscopy.The Diagnostic Yield of Colonoscopy Stratified by Indications.The yield and cost of colonoscopy in patients with metastatic cancer of unknown primary.