Phase 3 Trial of eRapa 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? Parti

Trial Details

NCT ID
NCT06950385
Phase
PHASE3
Sponsor
Rapamycin Holdings Inc.
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • eRapa (encapsulated rapamycin)
  • Placebo
Locations (sample)
  • Arcadia, California, United States|34.13973,-118.03534
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Orlando, Florida, United States|28.53834,-81.37924
  • Weston, Florida, United States|26.10037,-80.39977

Key Eligibility Criteria

  • 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 rect…
  • Contraceptive use by participants or participant partners until at at least 12 weeks after stopping study treatment.

For full eligibility, visit ClinicalTrials.gov.

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