Clinical Trials Logo
  1. Home
  2. Familial Adenomatous Polyposis
  3. NCT05552755

Evaluate REC-4881 in Patients With FAP — TUPELO  

Familial Adenomatous Polyposis Clinical Trial

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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552755
Study type Interventional
Source Recursion Pharmaceuticals Inc.
Contact Recursion Pharmaceuticals
Phone 385-374-1724
Email clinicaltrials@recursionpharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 10, 2023
Completion date July 2026
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Completed NCT02961374 - Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer Phase 2
Completed NCT01483144 - Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Completed NCT00641147 - Curcumin in Treating Patients With Familial Adenomatous Polyposis Phase 2
Recruiting NCT03471403 - Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Not yet recruiting NCT04531930 - Colorectal Adenoma Canceration in FAP
Recruiting NCT04678011 - A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy
Recruiting NCT04677998 - A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Completed NCT00927485 - Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP) N/A
Recruiting NCT00253812 - Adenoma Detection Rate:NBI, AFI, Chromoscopic or Standard Endoscopy N/A
Withdrawn NCT00248053 - Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients Phase 2
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research
Completed NCT04674228 - Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01
Completed NCT01656746 - Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease N/A
Completed NCT00808743 - Prevention of Progression of Duodenal Adenomas in Patients With Familial Adenomatous Polyposis Phase 2/Phase 3
Active, not recruiting NCT03847636 - CryoBalloon Ablation for Treatment of Duodenal Adenomas N/A
Not yet recruiting NCT05112822 - Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP) Phase 1
Recruiting NCT02656134 - Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP) N/A
Withdrawn NCT01245816 - A Trial of Low Dose Sulindac Combined With Eflornithine in Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Recruiting NCT04709445 - Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses N/A