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Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Recruiting
18 years and older
All
Phase 2

The study is a multi-site phase II double-blind randomized trial. Subjects will be randomized into placebo arm or intervention arm with low dose (0.5 mg) eRapa (encapsulated rapamycin) Monday-Friday for one year or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for 2 years, then every 6 months for 2 years, then annually following registration. Some patients may also concurrently receive BCG immune therapy maintenance (weekly for 6 weeks for induction period, weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 7 maintenance cycles following tumor removal) per standard of care. Patient-reported outcome (PRO) assessments, cognitive assessments, and physical assessments will be completed according to the study calendar. Research blood to assess safety, immune response and rapamycin level will be collected regularly throughout the study period. Participants will be followed for up to 4 years following enrollment.

Study details
    Non-muscle Invasive Bladder Cancer

NCT04375813

Rapamycin Holdings, Inc. dba Emtora Biosciences

19 February 2024

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