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