NCT03298958

Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Rapamycin	Subject will be randomized to one of the 2 arms
DRUG	Placebo Oral Tablet	Subject will be randomized to one of the 2 arms

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-02-01
• Completion: 2022-05-01
• First posted: 2017-10-02
• Last updated: 2019-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study