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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
Must not have
Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
Taking oral glucocorticoids at the time of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Summary
This study is evaluating whether a drug which is used to prevent organ rejection in transplant patients may also help prevent cancer from returning.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any active cancer except for skin cancer.
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I am currently taking oral glucocorticoids.
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I am unable to understand and agree to the study's details on my own.
Select...
I have received BCG treatment directly into my bladder in the past.
Select...
My bladder cancer has grown into the muscle layer or beyond.
Select...
I have been treated with Rapamycin before.
Select...
I am 17 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cognitive Function
Change in Handgrip Strength
Change in Short Physical Performance Battery
+3 moreTrial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bladder cancer treatments often target specific pathways to inhibit tumor growth and progression. One such pathway is the mTOR (mechanistic target of rapamycin) pathway, which is crucial for cell growth, proliferation, and survival.
Inhibitors like rapamycin (and its encapsulated form, eRapa) work by blocking this pathway, thereby slowing down or stopping cancer cell growth. This is particularly important for bladder cancer patients as it offers a targeted approach to treatment, potentially reducing tumor size and preventing relapse.
Other common treatments include chemotherapy, which uses drugs to kill rapidly dividing cells, and immunotherapy, which boosts the body's immune system to fight cancer cells. Understanding these mechanisms helps patients and doctors make informed decisions about the most effective treatment strategies.
New treatments for bladder cancer: when will we make progress?
New treatments for bladder cancer: when will we make progress?
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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
13,938 Previous Clinical Trials
41,024,208 Total Patients Enrolled
Robert S Svatek, MD, MSCIPrincipal InvestigatorUT Health San Antonio
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am not taking oral glucocorticoids.I do not have any active cancer except for skin cancer.I am currently taking oral glucocorticoids.All visible tumors were removed or confirmed absent by a doctor within the last 3 months.I have localized prostate cancer and am on an active surveillance program.I have no cancer history except for certain skin cancers, early-stage cancers I've recovered from, or any cancer I've been free from for 5 years.I am unable to understand and agree to the study's details on my own.My scans show no cancer spread and a recent surgery confirmed my cancer is still early stage.I have received BCG treatment directly into my bladder in the past.My bladder cancer is non-muscle invasive and was diagnosed within the last 90 days.I have never had BCG treatment directly into my bladder.I do not have any ongoing, untreated infections.My scans show cancer has spread to my lymph nodes or other areas.My bladder cancer has grown into the muscle layer or beyond.I have been treated with Rapamycin before.I am 17 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: Active Study Drug Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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