Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

STATUS

Recruiting
End date

Jun 5, 2029
participants needed

150
sponsor

Rapamycin Holdings, Inc. dba Emtora Biosciences

Updated on 19 February 2024

See if I qualify

Summary

eRapa (encapsulated rapamycin) will be investigated for secondary prevention in patients with diagnosed non-muscle invasive bladder cancer (NMIBC) through a phase II double-blind randomized controlled trial of long-term (one year) prevention with eRapa versus placebo. The primary hypothesis is that eRapa decreases the risk of cancer relapse for 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.

Description

The study is a multi-site phase II double-blind randomized trial. Subjects will be randomized into placebo arm or intervention arm with low dose (0.5 mg) eRapa (encapsulated rapamycin) Monday-Friday for one year or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for 2 years, then every 6 months for 2 years, then annually following registration. Some patients may also concurrently receive BCG immune therapy maintenance (weekly for 6 weeks for induction period, weekly for 3 weeks at 3 months, 6 months, and then every 6 months for a total of 7 maintenance cycles following tumor removal) per standard of care. Patient-reported outcome (PRO) assessments, cognitive assessments, and physical assessments will be completed according to the study calendar. Research blood to assess safety, immune response and rapamycin level will be collected regularly throughout the study period. Participants will be followed for up to 4 years following enrollment.

Details

Condition	Non-muscle Invasive Bladder Cancer
Age	18years - 100years
Treatment	Placebos, eRapa
Clinical Study Identifier	NCT04375813
Sponsor	Rapamycin Holdings, Inc. dba Emtora Biosciences
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or T1) bladder cancer within 90 days prior to enrollment
	Able to give informed consent
	years or older
	Patients must not be taking oral glucocorticoids at the time of registration
	Not have active, uncontrolled infections
	No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
	Patients with localized prostate cancer who are being followed by an active survelillance program are also eligible
	Patients must not be pregnant or nursing, as the use of Intravesical BCG is not recommended during pregnancy. Women/ men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Both male and female patients will be required to disclose contraception method during screening and agree to continue to use that contraception method through the end of their participation in the study
	Patients must have had all grossly visible papillary tumors removed within 90 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 90 days prior to registration
	Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days prior to registration. Patients with T1 disease must have re-resection confirming T1 disease within 90 days prior to registration
	Patients must no have received prior intravesical BCG
Exclusion Criteria
	Have muscle-invasive or higher (T2) bladder cancer
	Unable to give informed consent
	Age 17 or younger
	Taking oral glucocorticoids at the time of registration
	Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
	Patients at risk of pregnancy that are unwilling or unable to take effective contraception during the study period, or patients that are nursing during the study period. Women/ Men of reproductive potential must have agreed to use an effective contraceptive method or will be considered ineligible for study participation
	Evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days prior to registration
	History of prior intravesical BCG

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note

Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Sign up as a volunteer to stay informed

Study AnnotationsStudy Notes

Add a private note

Send Notes

Study Definition

Add a private note