Clinical trial · Interventional
Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding was received, no subjects were enrolled
Summary
Brief summary (as posted)
The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Rapamycin | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Oral Tablet
- description
- Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence
- interventionNames
- Drug: Placebo Oral Tablet
- type
- ACTIVE_COMPARATOR
- label
- Sirolimus (Rapamycin) 0.5 mg/day for 2 years
- description
- Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence
- interventionNames
- Drug: Rapamycin
Primary outcomes (1)
- measure
- Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer within 60 days prior to enrollment * Be able to give informed consent * Be age 18 or older * Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids) * Not have active, uncontrolled infections * Not be on agents known to alter rapamycin metabolism significantly * Not have a reported history of liver disease (e.g. cirrhosis) * Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin. * Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy. Exclusion Criteria: * Have muscle-invasive (≥T2) bladder cancer * Unable to give informed consent * Age \< 18 * Immunosuppressed state (e.g. HIV, use of chronic steroids) * Active, uncontrolled infections * On agents known to alter rapamycin metabolism significantly * Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin) * Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy. * Individuals with a reported history of liver disease (e.g. cirrhosis)
References
Publications (0)
Data not yet available