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eRapa for Bladder Cancer Prevention

Phase 2

Recruiting

Led By Robert S Svatek, MD, MSCI

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

18 years or older

Patients must not be taking oral glucocorticoids at the time of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will study whether eRapa can prevent cancer relapse in patients with NMIBC. Secondary hypotheses are that eRapa can improve certain immune parameters and improve cognition and physical function without adversely affecting patient-reported outcomes and quality of life.

Who is the study for?

This trial is for adults over 18 with non-muscle invasive bladder cancer diagnosed within the last 90 days. They must not be pregnant, nursing, or taking oral glucocorticoids and should agree to use contraception. Those with localized prostate cancer under surveillance may join, but those with muscle-invasive bladder cancer or other active cancers (except certain skin cancers) cannot.Check my eligibility

What is being tested?

The study tests if eRapa can prevent bladder cancer from coming back compared to a placebo. Participants will take the treatment for one year in this phase II trial where neither they nor the doctors know who's getting eRapa or placebo. The trial also looks at how eRapa affects immunity, cognition, physical function, and quality of life.See study design

What are the potential side effects?

While specific side effects are not listed here, rapamycin can typically cause mouth sores, diarrhea, nausea; affect blood counts and cholesterol levels; increase infection risk; and potentially impact kidney function among others.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am not taking oral glucocorticoids.

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I have never had BCG treatment directly into my bladder.

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I do not have any ongoing, untreated infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Cognitive Function

Change in Handgrip Strength

Change in Short Physical Performance Battery

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Study Drug GroupActive Control1 Intervention

Patients will be given 0.5mg eRapa (encapuslated rapamycin) orally each weekday (Monday-Friday) for one year.

Group II: Placebo GroupPlacebo Group1 Intervention

Patients will be given a placebo (visually identical to the eRapa (encapsulated rapamycin)) orally each weekday (Monday-Friday) for one year.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rapamycin Holdings, Inc. dba Emtora BiosciencesLead Sponsor

2 Previous Clinical Trials

45 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,839 Total Patients Enrolled

Robert S Svatek, MD, MSCIPrincipal InvestigatorUT Health San Antonio

Media Library

Active Study Drug Group Clinical Trial Eligibility Overview. Trial Name: NCT04375813 — Phase 2

Bladder Cancer Research Study Groups: Placebo Group, Active Study Drug Group

Bladder Cancer Clinical Trial 2023: Active Study Drug Group Highlights & Side Effects. Trial Name: NCT04375813 — Phase 2

Active Study Drug Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375813 — Phase 2

Frequently Asked Questions

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

What is the estimated enrollment size of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this investigation initiated on January 25th 2021 and is still recruiting participants. 166 individuals are desired from 4 separate research locations."

Answered by AI

Has the Active Study Drug Group received governmental sanction?

"There is minimal prior clinical evidence in support of Active Study Drug Group's safety, making it a score 2 on our team at Power's ranking."

Answered by AI

Is this research study currently open for enrollment?

"Verified. Information hosted on clinicaltrials.gov confirms that this experiment was initiated on January 25th 2021, and is still actively recruiting patients for participation across 4 different centres. The total number of participants needed amounts to 166 individuals."

Answered by AI

What precedential research has been done with the Active Study Drug Group?

"Presently, 125 trials are being conducted on Active Study Drug Group, 13 of which are in the last testing phase. Mainly occurring in Cincinnati, Ohio, there exist over a thousand other sites conducting these investigations around the globe."

Answered by AI

What conditions can be remedied with the Active Study Drug Group?

"Active Study Drug Group is frequently administered to prevent organ transplant rejection, as well as treat liver and kidney-related ailments such as disease and renal angiomyolipomas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

2021. "Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04375813.

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