Trial Contacts

Primary Investigator: Bryson Katona, MD, PhD
Research Coordinator: Julie Starr
jstarr@mail.med.upenn.edu
215-349-8527

Studies

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)

Sponsor: Recursion Pharmaceuticals Inc.
Primary Investigator: Bryson Katona, MD, PhD
CONTACT: Julie Starr (julie.starr@pennmedicine.upenn.edu or 215-349-8527)

Inclusion Criteria:

  • Male or female and ≥ 55 years of age
  • Have provided written informed consent to participate in the study
  • Diagnosis of phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site
  • Genetic diagnosis of FAP with APC gene mutation
  • Has undergone colectomy or subtotal colectomy
  • No significant cardiovascular abnormalities
  • Left ventricular ejection fraction of >50% as determined by echocardiogram
  • No significant hematopoietic abnormalities
  • No significant hepatic abnormalities
  • No significant renal abnormalities

Exclusion Criteria:

  • No clinically significant laboratory abnormality, medical or psychiatric illness
  • Has had prior pelvic irradiation
  • Has gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881
  • Has received treatment with other investigational agents prior to Study Day 1
  • Treatment with other FAP-directed drug therapy within 8 weeks of screening endoscopy (Part 2 only)
  • Is currently under treatment for desmoid tumors
  • Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1
  • Use of strong CYP3A inhibitors or inducers prior to Study Day 1
  • History of an ongoing or newly diagnosed eye abnormality
  • Cancer at screening endoscopy in GI tract (including stomach, duodenum, and colon/rectum/pouch) (Part 2 only)
  • Has a large polyp (>1 cm) not amenable to complete removal
  • Has active pancreatitis secondary to pancreatic duct obstruction
  • Has active gall bladder disease
  • Is pregnant, lactating or is planning to attempt to become pregnant during the study
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