TUPELO Trial of
REC-4881 in Familial Adenomatous Polyposis
A Phase 1b/2, Multicenter Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of REC-4881 in Patients with Familial Adenomatous Polyposis
If you have a disease called familial adenomatous polyposis, or FAP, you may be eligible to take part in a study to test the safety and efficacy of an investigational drug called REC-4881.
To be eligible, you must be 18 years of age or older, have familial adenomatous polyposis, and have already had surgery to remove a portion or the whole large intestine (an operation known as a colectomy or subtotal colectomy). You might also be eligible if you have a Desmoid tumor and you are not receiving treatment for this.
There are two parts to the study: Part 1 and Part 2. Part 1, which is now complete, studied how someone's body processes REC-4881 (a process known as “pharmacokinetics” or “PK”).
Part 2 includes two stages: “Dose Finding” and “Cohort Expansion”. In the Dose Finding stage, increasing amounts (or doses) of REC-4881 will be tested to see the safety and tolerability of REC-4881. One or two amounts which are found to be safe and tolerable during this stage of the study will then be used in the second stage of the study (the Cohort Expansion). Here, the safety and tolerability of the selected doses of REC-4881 will be tested further, as well as how well the drug works.
Part 1
Seven participants were enrolled and received a single dose and 14 daily doses of REC-4881 or placebo (an inactive substance that looks like the drug). This part of the study looked at the drug’s safety and how a person’s body processes it (a process known as PK/PD).
Part 2
This is the larger part of the study and will enroll approximately 60 more people. It is an open label trial, and everyone who participates will receive REC-4881.
Part 2 began with the Dose Finding stage, to find the right amount of the drug to study, and 4 mg was identified. “Cohort Expansion” is now ongoing with this 4 mg dose, which people who participate take once a day.
A total of around 30 people will take part in the study for each dose of REC-4881. A Futility Assessment has been completed (after approximately 10 people at each dose being tested had at least one on-treatment endoscopy), and passed the threshold to proceed.
The Risks of Taking Part in a Clinical Trial
This clinical trial is meant to study an investigational medication, meaning that neither the safety nor the effectiveness of the drug has been established. Taking part in this study may involve risks that are currently unknown. The known risks of taking part in this study will be explained to you during the informed consent process. If you are considering joining the trial, talk to your doctor about the clinical study. If you are interested in taking part, you will have the chance to ask questions and learn about these risks, so you can decide if the study is right for you.
This study will be conducted at approximately 15-20 sites in the United States. If you are interested in participating, please visit clinicaltrials.gov.
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