← Back to Search

mTOR Inhibitor

Encapsulated Rapamycin (eRapa) for Adenomatous Polyposis

Phase 2

Waitlist Available

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

Male or female, age at least 18 years at the time of consent.

Phenotypic familial adenomatous polyposis (FAP) with disease involvement of the colorectum by either genetic or clinical diagnosis: Adenomatous polyposis coli (APC) germline mutation with or without family history, or with greater than a cumulative lifetime history of (>) 100 adenomas in large intestine and a family history of FAP, or FAP phenotype post colectomy for polyposis with a family history of FAP. Minimum number of polyps required for enrollment is 10.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up following patients out to 6 and 12 months.

Awards & highlights

Study Summary

This trial is testing whether eRapa can reduce the number of polyps in patients with FAP.

Eligible Conditions

Familial Adenomatous Polyposis

Eligibility Criteria

Inclusion Criteria

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

+1 more

Other outcome measures

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

Cohort 3 will receive 0.5 mg of eRapa daily.

Group II: 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 III: Cohort 1Experimental Treatment1 Intervention

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cancer Insight, LLC dba LumabridgeUNKNOWN

Rapamycin Holdings, Inc. dba Emtora BiosciencesLead Sponsor

2 Previous Clinical Trials

181 Total Patients Enrolled

LumaBridgeUNKNOWN

3 Previous Clinical Trials

162 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical treatments is Encapsulated Rapamycin (eRapa) primarily used for?

"Encapsulated Rapamycin (eRapa) is primarily used to combat rejection in transplants, livers and other organs. Additionally, it has been found effective for treating a range of conditions such as disease, kidney issues, and renal angiomyolipomas."

Answered by AI

Are additional participants being sought for this trial?

"As indicated on clinicaltrials.gov, this medical trial has ceased its search for new candidates since October 3rd 2022; however, there are an array of other studies actively recruiting patients at present and 1020 in total."

Answered by AI

How many participants are enrolled in this trial thus far?

"This trial is not currently open for patient recruitment. It was initially posted on January 18th 2021, and had its most recent update October 3rd 2022. If you are looking to participate in other studies, 895 colorectal cancer trials and 125 eRapa clinical trials have openings for participants at present."

Answered by AI

What objective are researchers hoping to accomplish through this investigation?

"This clinical trial is designed to evaluate the frequency and severity of adverse events in those who take low doses of eRapa while also assessing its impact on polyp burden, Spigelman Stage Score, and International Society for Gastrointestinal Hereditary Tumors Stage. Informed consent must be obtained within 30 days after study participation ends. The assessment will include measuring changes from baseline levels at 6 months and 12 months regarding colorectal polyps (percentage change), adenomas size/histology/dysplasia (Spigelman scoring system) as well as mutations affecting gastrointestinal tumors (International Society for Gastrointestinal"

Answered by AI

Have researchers previously conducted research surrounding eRapa?

"Currently, 13 clinical trials for Encapsulated Rapamycin (eRapa) are in their final stage with 125 studies live across the country. Notably, 1074 locations offer these medical investigations including a few in Cincinnati, Ohio."

Answered by AI

In what capacity is this medical trial being managed across various sites?

"The medical trial is being administered in 7 distinct locations, including the University of Michigan (Ann Arbor), Cleveland Clinic (Cleveland) and Ohio State University Wexner Medical Center (Columbus). Other sites are also involved."

Answered by AI

Has Encapsulated Rapamycin (eRapa) attained regulatory authorization from the FDA?

"The team at Power has determined that the safety of eRapa is a level 2 due to its Phase 2 status, which indicates there are limited findings supporting efficacy but some evidence confirming safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of eRapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance

2021. "Trial of eRapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230499.

All > Familial Adenomatous Polyposis