Familial Adenomatous Polyposis (FAP)Phase 3SERENTANCT06950385
Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis
A Phase 3 study testing eRapa (encapsulated rapamycin) in people with Familial Adenomatous Polyposis (FAP), run by Rapamycin Holdings Inc. at 29 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Adenomatous Polyposis (FAP)
- What is being tested?
- eRapa (encapsulated rapamycin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 18 Jul 2025to Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥18 years of age inclusive.
- Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing.
- Participant must have at least 1 of the following high-risk features: >100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum/sigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening.
- Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.
- Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment.
- Willing to undergo endoscopic evaluation.
Who cannot join
- Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy.
- Participant has any polyps ≥8 mm in the duodenum, colon, rectum, or ileal pouch remaining after screening endoscopy (polyps ≥8 mm are to be resected during screening endoscopy).
- Participant has had surgery within 6 weeks of the trial.
- Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention.
- Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency.
- Participant has active and clinically significant tuberculosis (positive Quantiferon Gold test), bacterial, fungal, or viral infection, including human immunodeficiency virus (HIV).
- Participant has any medical or social condition that, in the opinion of the Investigator, might increase participant risk if enrolled, prevent participant compliance to trial procedures, or present an unacceptable confound to safety or clinical trial data.
Trial locations and contacts
29 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 7 countries
United States18 sites, 18 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Erika Koeppe, 734-998-1274, eskoeppe@med.umich.edu
- Recruiting
City of Hope
Arcadia, California, 91007
Gregory Idos, 626-218-2570, gidos@coh.org
Andrew Fernandez, andfernandez@coh.org
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Lisa Datta, 410-614-1982, erapastudy@live.johnshopkins.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Samantha Kuney, 617-582-9095, ColonScreening@dfci.harvard.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60615
Sonia Kupfer, 773-702-6140, cancerclinicaltrials@bsd.uchicago.edu
Kristi Kearney, kristi.kearney@uchicagomedicine.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Lindsey Reardon, (216) 444-7493, Reardol3@ccf.org
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Kebire Gofar, 614-600-2113, kebire.gofar@osumc.edu
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Kay Reiner, 570-214-5421, kmreiner1@geisinger.edu
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Annie Lincoln, 919-923-4430, aglincoln@mdanderson.org
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Llana Abella, 913-584-0533, labella@kumc.edu
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06520
Edgar Benitez, 2033936591, edgar.benitez@yale.edu
- Recruiting
Digestive & Liver Center of Florida
Orlando, Florida, 32825
Alisa Del Vecchio, 407-490-4526, alisa.delvecchio@dlcfl.com
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Sara Booz, 412-864-7516, boozs@upmc.edu
- Recruiting
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Alicia Reyes, (206)-341-1450, mariaalicia.reyes@commonspirit.org
- Recruiting
University of Washington - Fred Hutchinson
Seattle, Washington, 98195
Brian Forester, (206) 685-1179, foerstb@uw.edu
- Recruiting
Department of Surgery, Section of Colon Rectal and Surgery
St Louis, Missouri, 63110
Asima Badic, 314- 362-2646, asimabadic@wustl.edu
- Recruiting
Georgetown University
Washington D.C., District of Columbia, 20057
Priyanth Kanth, 202-444-1431, priyanka.kanth@medstar.net
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Michael Nicolas, 954-659-6213, nicolam4@ccf.org
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona
Frencesc Balaguer Prunes, fprunes@clinic.cat
- Recruiting
Hospital Comarcal de Inca
Inca
Jose Reyes Moreno, jose.reyes@hcin.es
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Luis Miguel Jiménez-Gomez, M.D, +34 915868522, luismiguel.jimenez@salud.madrid.org
- Recruiting
Hospital La Fe de Valencia
Valencia
Marco Bustamante, bustamante_mar@gva.es
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Giulia Martina Cavestro, M.D, XXX-XXX-XXXX, cavestro.giuliamartina@hsr.it
- Recruiting
Istituto Nazionale dei Tumori
Milan
Marco Vitellaro, M.D, + 39 02 23902540, marco.vitellaro@istitutotumori.mi.it
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Evelien Dekker, e.dekker@amsterdamumc.nl
- Recruiting
Radboud University Medical Center
Nijmegen
Tanya Bisseling, tanya.bisseling@radboudumc.nl
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen
John Karstensen, john.gasdal.karstensen@regionh.dk
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Bonn
Bonn
Robert Hüneburg, robert.hueneburg@ukbonn.de
Puerto Rico1 site, 1 recruiting
- Recruiting
Hospital Oncologico - Puerto Rico Medical Center
Rio Piedras, 00935
Ramon Vega, 787-407-3333, ramon.vega@panoncologytrials.com
About this study
Official title: A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis
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?
Read more
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.
Read the detailed description
This is a Phase 3, multi-site, prospective, randomized, double-blind, placebo-controlled trial of eRapa administered to patients with FAP who are at high risk of disease progression. 168 patients with FAP will be enrolled in the trial and randomized 2:1 to receive 0.5 mg eRapa or matching placebo orally, once a day (QD) every other week. There is no minimum treatment duration as this is an event-driven trial; however, the intervention period will continue until disease progression, participant withdrawal from treatment, or until the overall trial endpoint is reached. Participant eligibility is restricted to patients under active surveillance for genetic or clinically diagnosed FAP and who have an intact colon; who are postcolectomy/subtotal colectomy and have documented residual polyps in the rectum/sigmoid or who are post-proctocolectomy with ileal-pouch anal anastomosis and documented polyps in the pouch. Eligible participants will undergo a baseline endoscopy and subsequent endoscopic procedures performed every 6 months to monitor for disease progression.
Randomized patients will be stratified based on the following disease characteristics:
- Intact colon versus post-surgical resection with retained rectum/sigmoid or pouch, and
- Duodenal polyposis (current Spigelman stage score ≤2 versus Spigelman stage score ≥3) For the purposes of this trial, high-risk for disease progression is defined as meeting one of the following:
- Patients who have intact colons and have >100 polyps but ≤500 polyps
- Patients who have retained rectum/sigmoid or ileal-pouch-anal anastomosis and have ≥10 polyps that are ≥3 mm in diameter, or
- Patients who have a history of duodenal polyposis Spigelman stage score of 3 or 4 with at least 1 duodenal polyp that has been removed within 18 months of screening.
Trial assessments should be conducted as per the Schedule of Activities with a visit occurring about once every 3 months.
Assessment of Spigelman stage will not require a biopsy unless the lesion has an abnormal appearance and/or is ≥10 mm.
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Being tested
- eRapa (encapsulated rapamycin), Placebo
- Keywords
- FAP, Polyposis, Polyps, ileal pouch
- Medical subject headings
- Adenomatous Polyposis Coli, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eRapa (encapsulated rapamycin)Drug
0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.
PlaceboDrug
Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal.
| Study group | Role | What they receive |
|---|---|---|
| eRapa | Experimental | 0.5 mg eRapa once a day (QD) every other week Receives: Drug: eRapa (encapsulated rapamycin) |
| Placebo | Placebo comparator | Placebo once a day (QD) every other week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) in high-risk patients with FAP treated with eRapa versus placebo.
- Death from any cause
- Cancer/high-grade dysplasia
- Major FAP-related surgery (e.g., colectomy, proctectomy, total proctocolectomy with ileal pouch anal anastomosis [IPAA], pouch resection, ileostomy, duodenectomy, or surgical ampullectomy)
- Advancement of Spigelman stage (not related solely to increase in polyp number)
- Meets criteria for surgery (consistent with United States [US] and European Union [EU] practice guidelines) (Yang, Gurudu et al. 2020, Zaffaroni, Mannucci et al.2024)
- Retained rectum/sigmoid or pouch (≥10 polyps ≥3 mm in size at baseline)
- Duodenum (Stage 3/4 and at least 1 polyp ≥10 mm removed in last 18 months)
Measured: 3 years
Secondary outcomes (6)
The safety and tolerability of eRapa in patients with FAP
-Frequency of all grades (as per the Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) treatment-emergent adverse events (TEAEs) in participants receiving eRapa;
- Frequency of Grade 3 and higher (as per the CTCAE v5.0) TEAEs in participants receiving eRapa
- Percentage of participants discontinuing eRapa treatment due to adverse drug reactions (ADRs)
Measured: 3 years
The effect of eRapa treatment on GI polyposis in patients with FAP
- Percent change from baseline in the PB (i.e., the sum of the diameters of all polyps >3 mm) at 6, 12, 18, 24, 30, and 36 months as observed by surveillance endoscopy Note: The total PB will be based on polyps observed in the upper GI tract (duodenum) and the lower GI tract (colon, retained rectum/sigmoid or pouch)
- Percent change from baseline in the PB in the upper GI tract (duodenum) at 6, 12, 18, 24, 30, and 36 months as observed by upper endoscopy
- Percent change from baseline in the PB in the lower GI tract (colon, retained rectum/ sigmoid or pouch) at 6, 12, 18, 24, 30, and 36 months as observed by lower endoscopy
Measured: 3 years
The effect of eRapa treatment on Spigelman stage score in patients with FAP
Change from baseline in Spigelman stage score at 6, 12, 18, 24, 30, and 36 months
Measured: 3 years
The effect of eRapa treatment on quality-of-life measures, assessed by the 5 level EuroQoL-5 Dimension (EQ-5D-5L)
-Change from baseline in EQ-5D-5L score at 6, 12, 18, 24, 30, and 36 months;
Measured: 3 years
Determine the immunomodulating effect of eRapa treatment in patients with FAP
- Change from baseline in T cell phenotypes and function at 12, 24, and 36 months
Measured: 3 years
The effect of eRapa treatment on quality-of-life measures, assessed by EORTC-30
-Change from baseline in EORTC-30 score at 6, 12, 18, 24, 30, and 36 months;
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start18 Jul 2025
- Primary completionJul 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous Polyposis (FAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rapamycin Holdings Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biodexa Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Gary Shangold, MD, Study director, Biodexa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950385
- Sponsor's protocol ID
- MTX230-301
- Acronym
- SERENTA
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Site, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of eRapa to Improve Clinical Outcomes in Patients With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT06950385
- Acronym / sponsor ID
- SERENTA / MTX230-301
- Conditions
- Familial Adenomatous Polyposis (FAP)
- Keywords
- FAP, Polyposis, Polyps, ileal pouch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Rapamycin Holdings Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biodexa Pharmaceuticals
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 3, multi-site, prospective, randomized, double-blind, placebo-controlled trial of eRapa administered to patients with FAP who are at high risk of disease progression. 168 patients with FAP will be enrolled in the trial and randomized 2:1 to receive 0.5 mg eRapa or matching placebo orally, once a day (QD) every other week. There is no minimum treatment duration as this is an event-driven trial; however, the intervention period will continue until disease progression, participant withdrawal from treatment, or until the overall trial endpoint is reached. Participant eligibility is restricted to patients under active surveillance for genetic or clinically diagnosed FAP and who have an intact colon; who are postcolectomy/subtotal colectomy and have documented residual polyps in the rectum/sigmoid or who are post-proctocolectomy with ileal-pouch anal anastomosis and documented polyps in the pouch. Eligible participants will undergo a baseline endoscopy and subsequent endoscopic procedures performed every 6 months to monitor for disease progression.
Randomized patients will be stratified based on the following disease characteristics:
- Intact colon versus post-surgical resection with retained rectum/sigmoid or pouch, and
- Duodenal polyposis (current Spigelman stage score ≤2 versus Spigelman stage score ≥3) For the purposes of this trial, high-risk for disease progression is defined as meeting one of the following:
- Patients who have intact colons and have >100 polyps but ≤500 polyps
- Patients who have retained rectum/sigmoid or ileal-pouch-anal anastomosis and have ≥10 polyps that are ≥3 mm in diameter, or
- Patients who have a history of duodenal polyposis Spigelman stage score of 3 or 4 with at least 1 duodenal polyp that has been removed within 18 months of screening.
Trial assessments should be conducted as per the Schedule of Activities with a visit occurring about once every 3 months.
Assessment of Spigelman stage will not require a biopsy unless the lesion has an abnormal appearance and/or is ≥10 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eRapa | Experimental | Drug: eRapa (encapsulated rapamycin)0.5 mg eRapa once a day (QD) every other week |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once a day (QD) every other week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be ≥18 years of age inclusive.
- Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing.
- Participant must have at least 1 of the following high-risk features: >100 polyps but ≤500 polyps in the colon, or ≥10 polyps in the retained rectum/sigmoid or ileal pouch (≥3 mm in size), or Spigelman stage 3 or 4 with at least 1 polyp ≥10 mm to be removed at baseline or on endoscopy performed within 18 months of screening.
- Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.
- Agree not to donate gametes for the purpose of reproduction until at at least 12 weeks after stopping study treatment.
Key exclusion criteria (7 listed)
- Participant has unresected or incompletely resected high-grade dysplasia or cancer within the duodenum, colon, rectum, or ileal pouch at screening endoscopy.
- Participant has any polyps ≥8 mm in the duodenum, colon, rectum, or ileal pouch remaining after screening endoscopy (polyps ≥8 mm are to be resected during screening endoscopy).
- Participant has had surgery within 6 weeks of the trial.
- Participant has active malignancy or history of malignancy diagnosed within 24 months of first dose of trial intervention.
- Participant has a history of, or currently has, an acquired or primary (congenital) immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eRapa (encapsulated rapamycin)0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. | Drug | eRapa |
| PlaceboCapsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. | Drug | Placebo |
Primary outcome
Progression-free survival (PFS) in high-risk patients with FAP treated with eRapa versus placebo.
Time frame: 3 years
* Death from any cause * Cancer/high-grade dysplasia * Major FAP-related surgery (e.g., colectomy, proctectomy, total proctocolectomy with ileal pouch anal anastomosis [IPAA], pouch resection, ileostomy, duodenectomy, or surgical ampullectomy) * Advancement of Spigelman stage (not related solely to increase in polyp number) * Meets criteria for surgery (consistent with United States [US] and European Union [EU] practice guidelines) (Yang, Gurudu et al. 2020, Zaffaroni, Mannucci et al.2024) * Retained rectum/sigmoid or pouch (≥10 polyps ≥3 mm in size at baseline) * Duodenum (Stage 3/4 and at least 1 polyp ≥10 mm removed in last 18 months)
6 secondary outcomes
The safety and tolerability of eRapa in patients with FAP
Time frame: 3 years
The effect of eRapa treatment on GI polyposis in patients with FAP
Time frame: 3 years
The effect of eRapa treatment on Spigelman stage score in patients with FAP
Time frame: 3 years
The effect of eRapa treatment on quality-of-life measures, assessed by the 5 level EuroQoL-5 Dimension (EQ-5D-5L)
Time frame: 3 years
Determine the immunomodulating effect of eRapa treatment in patients with FAP
Time frame: 3 years
The effect of eRapa treatment on quality-of-life measures, assessed by EORTC-30
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary Shangold, MD study director
Biodexa
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eRapa (encapsulated rapamycin) in people with Familial Adenomatous Polyposis (FAP), run by Rapamycin Holdings Inc. at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Spain, Italy, Netherlands, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vice President Clinical Operations (XXX-XXX-XXXX, jim.kostka@biodexapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) in high-risk patients with FAP treated with eRapa versus placebo. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.