Are you currently living with Familial Adenomatous Polyposis (FAP)?
The Serenta FAP clinical trial is a Phase 3 trial for people diagnosed with familial adenomatous polyposis (FAP). The purpose of this trial is to test an experimental FAP disease treatment, eRapa, to evaluate its ability to improve clinical outcomes in FAP patients vs placebo (inactive substance).
What is Familial Adenomatous Polyposis (FAP)?
What is FAP?
Familial Adenomatous Polyposis (FAP) is a rare, inherited genetic condition characterized by the development of hundreds to thousands of polyps (clumps of cells) in the large intestine (colon) and rectum. These polyps typically begin to appear during adolescence or early adulthood. If left untreated, they have an almost 100% chance of developing into colorectal cancer, often before the age of 40.
There are milder forms of FAP, such as attenuated familial adenomatous polyposis (AFAP), which involve fewer polyps and a later onset of cancer. FAP can also manifest as part of related syndromes, including Gardner syndrome and Turcot syndrome, which may involve tumors or other symptoms outside the gastrointestinal tract.
What causes FAP?
FAP is caused by mutations in the APC gene, a tumor suppressor gene responsible for regulating cell growth. When this gene is mutated, it leads to uncontrolled cell growth and polyp formation in the colon and rectum. The condition is inherited in an autosomal dominant manner, meaning that if one parent carries the mutation, there is a 50% chance their child will inherit it. However, in about 20-30% of cases, the mutation occurs spontaneously without being inherited.
The APC gene mutation can also lead to polyps in other parts of the gastrointestinal tract and increase the risk of non-gastrointestinal tumors, such as thyroid cancer or hepatoblastoma (a rare liver cancer in children)
Where can I learn more?
To learn more about FAP visit:
What is the Serenta Trial?
The Serenta trial is a Phase 3 clinical trial for people diagnosed with familial adenomatous polyposis (FAP). The purpose of this trial is to test an experimental treatment, eRapa, to evaluate its ability to improve clinical outcomes in FAP patients vs placebo (inactive substance).
This trial is double-blind, which means you, your trial doctor and the trial team will not know which trial intervention you will be receiving.
Trial participants may be able to join the trial if they meet the following requirements:
18 years or older
Diagnosed FAP
With or without family history.
Have at least 1 of the following high-risk features:
- participants who have intact colons and have >100 but <=500 polyps,
- participants who have retained rectum/sigmoid or ileal-pouch-anal anastomosis and have >=10 polyps that are >=3mm in diameter, or
- participants who have history of duodenal polyposis Spigelman stage of 3 or 4 with >=1 duodenal polyp >=10mm that has been removed within 18 months of screening.
What to expect from this FAP clinical trial
Entry
Randomization
Trial Period
eRapa 0.5mg once daily every other week or placebo once daily every other week
Every 3 Months
Visits every 3 months until:
- Disease progression
- Withdrawal from treatment
- Overall trial endpoint reached
Endpoint
Expanded access program
What is a Phase 3 Clinical Trial?
A phase 3 clinical study is a large research trial that tests how well a new treatment works and how safe it is compared to the current standard treatment or a placebo. These studies usually involve hundreds to thousands of patients and are conducted at multiple locations. The goal is to confirm the effectiveness of the new treatment, monitor side effects, and gather information to support approval by regulatory authorities. Phase 3 trials are typically the last step before a new treatment can be approved for general use.
Serenta Study locations
Participating Countries
The Serenta Trial is also recruiting in the countries listed below. For more information please visit ClinicalTrials.gov
USA
Germany
Denmark
The Netherlands
Spain
Participating Clinics - USA
Benaroya Research Institute at Virginia Mason
Clinical Research Coordinator II
Center for Digestive Health Clinical Research
Clinical Research Program
1100 9th Avenue,
Seattle, WA 98101, USA
Study Contact: Alicia Reyes
Email: mariaalicia.reyes@commonspirit.org
Phone: (206) 341-1450
City of Hope
1500 East Duarte Road
Duarte, CA 91010, USA
PI: Greg Idos, MD
Email: gidos@coh.org
Phone: (626) 218-2570
Cleveland Clinic, Cleveland Ohio
9500 Euclid Ave
Cleveland, Ohio 44195, USA
PI: Carol Burke, MD
Study Contact: Lindsey Reardon
Research Coordinator
Email: Reardol3@ccf.org
Phone: (216) 444-7493
Cleveland Clinic, Weston Florida
2950 Cleveland Clinic Blvd
Weston, Florida 33331, USA
PI: Brenda Jimenez, MD
Study Contact: Ana Paula Lacombe, MBA
Manager, Research Program
Email: Lacomba3@ccf.org
Phone: (786) 679-8916
Dana Farber Cancer Institute
450 Brookline Ave,
Boston, MA 02115, USA
Study Contact: Samanatha Kuney
Email: Samantha_Kuney@dfci.harvard.edu
Phone: (617) 582-9095
Digestive & Liver Center of Florida
100 N Dean Road, Suite 200B
Orlando, FL 32825, USA
Study Contact: Alisa M.D. DelVecchio, Site Director
Email: alisa.delvecchio@dlcfl.com
Phone: (407) 490-4526
Geisinger Medical Center
100 N. Academy Avenue, Danville, PA 17822, USA
Study Contact: Kay Reiner, MPH, BSN, RN, CCRC, Clinical Research Coordinator III
Phone: (570) 214-5421
Georgetown University
100 Irving St.
Washington, DC 20010, USA
PI: Dr. Priyanka Kanth
Email: priyanka.kanth@medstar.net
Phone: (202) 444-1431
Johns Hopkins University
733 N Broadway
Baltimore, MD 21205, USA
Study Contact: Lisa Datta
Email: erapastudy@live.johnshopkins.edu
Phone: (410) 614-1982;
Ohio State University
Wexner Medical Center, 410 West 10th Avenue, Columbus, OH43210, USA
PI: Peter Stanich
Email: peter.stanich@osumc.edu
Phone: (614) 600- 2113 / (614) 293-8400
Pan American Center for Oncology Trials
Hospital Oncologico – Puerto Rico Medical Center, Second Floor - PanOncology Trials, Barrio Monacillos,
Rio Piedras, PR 00935, USA
PI: Marcia Cruz Correa
Email: marcia.cruzcorrea@panoncologytrials.com
Phone: (787) 407-3333
University of Chicago
5758 South Maryland Avenue
Chicago, IL 60637, USA
Study Contact: Ophir Gilad
Email: ophirg@bsd.uchicago.edu
Phone: (773) 834-7414
University of Kansas Medical Center
3901 Rainbow Boulevard, MS 10123,
Kansas City, KS 66160, USA
PI: Ajay Bansal
Email: abansal@kumc.edu
Phone: (913) 584-0533
University of Michigan
1500 East Medical Center, Ann Arbor, MI 48109, USA
PI: Elena Stoffel
Email: estoffel@med.umich.edu
Phone: (734) 998-1274
University of Pittsburgh Medical Center
5200 Centre Avenue
Suite 409
Pittsburgh, PA, USA
Study Contact: Sara Booz, Clinical Research Coordinator
Email: boozs@upmc.edu
Phone: (412) 864-7516
The University of Texas M.D. Anderson Cancer Center
1515 Holcombe Blvd, Houston, TX 77030, USA
Study Contact: Annie Lincoln, MS, PhD, Research Assistant II
Phone: (919) 923-4430
University of Washington
1959 NE Pacific Street
Box 356424
Seattle WA98195, USA
Study Contact: Brian Forester
Email: foerstb@uw.edu
Phone: (206) 685-1179
Washington University
Department of Surgery, Section of Colon Rectal and Surgery
660 S. Euclid Avenue Saint Louis. MO, 63110. USA
Study Contact: Asima Badic
Email: asimabadic@wustl.edu
Phone: (314) 362-2646
Yale Cancer Center
333 Cedar St, New Haven, CT 06510, USA
PI: Edgar Benitez
Email: edgar.benitez@yale.edu
Phone: (203) 393-6591
Interested in the Serenta FAP Trial?
Contact a study clinic near you or visit clinicaltrials.gov.
Frequently Asked Questions
What is the purpose of the Serenta Trial?
This research trial is testing an investigational drug, eRapa (rapamycin) compared to placebo in people with FAP. It will help answer the following questions:
- How effective is eRapa in managing FAP?
- How safe is eRapa and are there any unwanted side effects?
How can I participate in the Serenta trial?
You can talk to a trial doctor to find out if you may qualify for the trial. Contact us at info@serentatrial.com.
What are the current treatment options for FAP?
Currently, there are no approved pharmaceutical treatments specifically for Familial Adenomatous Polyposis (FAP). Treatment mainly focuses on managing the condition through regular monitoring and surgical options to reduce the risk of cancer. Surgery to remove the colon or rectum is often recommended to prevent colorectal cancer, which is a common complication of FAP. Researchers are actively studying new treatments, including clinical trials, to find effective medical therapies for FAP.
Is there a cost to participate?
There is no cost to participate in the Serenta trial. The investigational drug, trial-related tests, assessments, and trial visits will be provided at no cost to you and your insurance company. If you decide to take part in the trial, you will receive trial-related care throughout the trial from a team of experienced doctors and nurses.
Do I need health insurance to participate in the trial?
No health insurance is required to participate.
Will I be compensated for time and travel?
Volunteers who take part in the trial may be compensated for travel costs and time in the trial. Please discuss this with the trial site when you are in contact with them.
What else do I need to consider?
The research team at your trial site will be able to explain more about what the Serenta trial will involve, and it is up to you to decide if you want to participate. Participation in this trial is voluntary. Whether or not you decide to participate in this trial will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
What are the risks and benefits?
There are risks and benefits of taking part in any clinical trial. For example, your health may be more closely monitored than it would have been otherwise. You may or may not benefit from the investigational drug (eRapa). It is not known if your condition will get any better; it may get worse. This trial is being conducted to learn more about the investigational drug. What we learn may help other FAP patients in the future. The known risks and benefits of participation are outlined in the informed consent form (ICF) that you must read and sign before you can take part in this trial. You should also discuss this question with your physician.
What if I don’t live near a research center?
Please contact us to explore further options; we are committed to supporting participants with travel logistics and expenses necessary to participate in the trial.
How frequently do I need to visit the site/research center?
The trial will run for up to 24 months from the time of recruitment of the final patient into the trial. The anticipated average time in the trial is likely to be about 33 months. During that time, you will visit the clinic on initiation and every 3 months thereafter until the conclusion of the trial or the occurrence of a predefined event.
Will I be able to participate in other clinical trials while enrolled in the Serenta trial?
Participants in the Serenta trial are restricted from participating in other studies in which they receive an investigational drug. Participation in an observational trial that does not require interventional treatment (e.g., another trial drug from a different trial) is permitted.
Has the investigational drug been tested in FAP previously and were the results promising?
The investigational drug (eRapa) was assessed in a phase 2 trial in 30 patients with FAP. In that trial, a majority of participants with FAP did demonstrate promising results in terms of their overall polyp burden. The results of that trial are available on the Biodexa Pharmaceuticals website. We are running the Serenta trial to confirm whether the results of the prior trial translate into broader clinically meaningful improvements in disease control in a larger group of patients.
Important Notice on Personal Information
To protect your privacy and comply with data protection regulations, please do not disclose any personal information (such as your full name, contact details, or medical history) through this website. We do not collect or process personal data via this platform. If you are interested in participating in the clinical trial, please contact your healthcare provider or the clinical trial site directly, where your information can be handled securely and confidentially in accordance with applicable privacy laws.
Your privacy and the confidentiality of your data are our highest priority. Any personal information related to the clinical trial will only be collected through official channels and with your informed consent as outlined in the clinical trial’s privacy policy.