← Back to Search

mTOR Inhibitor

eRapa for Adenomatous Polyposis

Phase 2

Recruiting

Research Sponsored by Rapamycin Holdings, Inc. dba Emtora Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Abilitiy to safely undergo endoscopy.

Ability to take oral medication and be willing to adhere to the eRapa regimen.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following patients out to 6 and 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Encapsulated Rapamycin (eRapa) taken by mouth to help patients with Familial Adenomatous Polyposis (FAP) reduce the number of polyps in their colon. The medication works by slowing down cell growth, aiming to manage this genetic condition more effectively. Rapamycin has shown potential in early research for preventing the development of polyps in FAP.

Who is the study for?

This trial is for adults over 18 with Familial Adenomatous Polyposis (FAP), who have at least 10 polyps and can undergo endoscopy. They must be able to take oral medication, follow the study plan, and not breastfeed or donate eggs. Women should use effective birth control during the study and for 12 weeks after.

What is being tested?

The trial tests Encapsulated Rapamycin (eRapa) in three different doses/schedules over a year on patients with FAP under surveillance to see if it reduces the number of polyps in their large intestine.

What are the potential side effects?

While specific side effects are not listed here, eRapa could potentially cause immune system suppression, increase infection risk, mouth sores, skin problems, or impact fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can safely have an endoscopy procedure.

Select...

I can take pills and will follow the eRapa treatment plan.

Select...

I have FAP with more than 10 polyps or a family history of it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ following patients out to 6 and 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~following patients out to 6 and 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and following patients out to 6 and 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the Recommended Phase 2 Dose (RP2D)

Efficacy of eRapa in delaying polyp progression in patients with FAP as measured by change in polyp burden over time.

Frequency and severity of adverse events associated with low dose eRapa in FAP patients

Secondary study objectives

Clinical effect of eRapa on International Society for Gastrointestinal Hereditary Tumors Stage.

Clinical effect of eRapa on Spigelman Stage Score.

Clinical effect of eRapa on duodenal polyp number and burden.

+2 more

Other study objectives

Explore correlation between immune markers influenced by mTOR inhibition and clinical outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Food EffectExperimental Treatment1 Intervention

Upon identification of the RP2D, after a 2 week washout (14 days), subjects will be randomized into a fed and fasted (2 weeks - 14 days) two period cross over, with an intervening 2 week washout (14 days) for a total of 2 months (8 weeks).

Group II: Cohort 3Experimental Treatment1 Intervention

Cohort 3 will receive 0.5 mg of eRapa daily.

Group III: Cohort 2Experimental Treatment1 Intervention

Cohort 2 will receive 0.5mg of eRapa daily with 7 days on therapy, followed by 7 days off therapy.

Group IV: Cohort 1Experimental Treatment1 Intervention

Cohort 1 will receive 0.5mg of eRapa every other day.

0 / 3Eligibility criteria met