Actively Recruiting
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
Led by Rapamycin Holdings Inc. · Updated on 2026-03-17
168
Participants Needed
26
Research Sites
284 weeks
Total Duration
On this page
Sponsors
R
Rapamycin Holdings Inc.
Lead Sponsor
B
Biodexa Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main goal of this clinical trial is to learn if the drug eRapa works to slow down the progression of disease in patients diagnosed with Familial Adenomatous Polyposis (FAP). Researchers will compare eRapa to Placebo. The questions to be answered by this trial are: * Does taking eRapa help to slow down the progression of the disease in patients with FAP? * Is eRapa a safe treatment for patients diagnosed with FAP? * What is the effect of eRapa on the number of polyps found in GI tract of patients diagnosed with FAP? * How does treatment with eRapa affect a patient's quality of life? Participants will: * Take eRapa or placebo once per day every other week until disease progresses (gets worse), stops taking part in the trial or dies. * Visit the clinic once every 3 months for check ups and tests. * Have an endoscopy at the start of the trial and then every 6 months to check on whether the disease is getting better or worse.
CONDITIONS
Official Title
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older.
- Participant must have documented Familial Adenomatous Polyposis confirmed by adenomatous polyposis coli genotype mutation testing.
- Participant must have at least one high-risk feature: more than 100 but 500 or fewer polyps in the colon; or 10 or more polyps in the retained rectum, sigmoid, or ileal pouch that are 3 mm or larger; or Spigelman stage 3 or 4 with at least one polyp 10 mm or larger removed at baseline or within 18 months before screening.
- Participant or their partner must use contraception during the study and for at least 12 weeks after stopping treatment.
- Participant agrees not to donate gametes for reproduction during the study and for at least 12 weeks after stopping treatment.
- Participant is willing to undergo endoscopic evaluations.
You will not qualify if you...
- Participant has unresected or incompletely resected high-grade dysplasia or cancer in the duodenum, colon, rectum, or ileal pouch at screening.
- Participant has any polyps 8 mm or larger remaining after screening endoscopy.
- Participant has had surgery within 6 weeks before the trial.
- Participant has active cancer or a history of cancer diagnosed within 24 months before the first dose.
- Participant has a history of or currently has an acquired or congenital immunodeficiency.
- Participant has active and clinically significant infections, including tuberculosis, bacterial, fungal, viral infections, or HIV.
- Participant has any medical or social condition that may increase risk, reduce compliance, or confound safety or trial data according to the investigator.
AI-Screening
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Trial Site Locations
Total: 26 locations
1
City of Hope
Arcadia, California, United States, 91007
Not Yet Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
3
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Actively Recruiting
4
Digestive & Liver Center of Florida
Orlando, Florida, United States, 32825
Actively Recruiting
5
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60615
Not Yet Recruiting
7
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
8
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Department of Surgery, Section of Colon Rectal and Surgery
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
15
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
16
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Actively Recruiting
18
University of Washington - Fred Hutchinson
Seattle, Washington, United States, 98195
Actively Recruiting
19
Copenhagen University Hospital
Copenhagen, Denmark
Actively Recruiting
20
Universitätsklinikum Bonn
Bonn, Germany
Actively Recruiting
21
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
22
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
23
Hospital Oncologico - Puerto Rico Medical Center
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
24
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
25
Hospital Comarcal de Inca
Inca, Spain
Not Yet Recruiting
26
Hospital La Fe de Valencia
Valencia, Spain
Actively Recruiting
Research Team
V
Vice President Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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