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Phase IIA Trial of Encapsulated Rapamycin (eRapa) to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden.
Details
| Lead sponsor | Rapamycin Holdings Inc. |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 30 |
| Start date | 2021-01-18 |
| Completion | 2025-03 |
Conditions
- Familial Adenomatous Polyposis
Interventions
- Encapsulated Rapamycin (eRapa)
Primary outcomes
- Frequency and severity of adverse events associated with low dose eRapa in FAP patients — All adverse events with start dates occurring any time after informed consent is obtained until 7 days (for non-serious adverse events) or 30 days (for serious adverse events) after the last day of study participation will be recorded.
Safety and tolerability of eRapa as determined by graded toxicity assessed throughout the trial per CTCAE v5.0. - Determine the Recommended Phase 2 Dose (RP2D) — After informed consent is obtained up to 30 days after the last day of study participation.
The Recommended Phase 2 Dose (RP2D) will be determined by examining and analyzing safety/ adverse events as reflected by Outcome 1, dose delays, dose reductions, withdrawal of treatment secondary to low-grade toxicities, and serum pharmacokinetic monitoring. - Efficacy of eRapa in delaying polyp progression in patients with FAP as measured by change in polyp burden over time. — Time for each patient is baseline to 6 months.
Percentage change from baseline in colorectal polyp burden as measure by endoscopy at 6 months.
Countries
United States