Sapanisertib for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+22 other locations

Joseph Kim, MD < Yale School of Medicine

Overseen byJoseph W. Kim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial studies how well sapanisertib works in treating patients with advanced or metastatic bladder cancer that have specific genetic mutations. Sapanisertib is taken by mouth and aims to stop cancer cell growth by blocking necessary enzymes.

Eligibility Criteria

This trial is for adults with advanced or metastatic bladder cancer that has specific genetic mutations (TSC1/TSC2). Participants must have had progression after platinum-based chemotherapy, be unfit for such treatment, or have recurred within 12 months of neoadjuvant/adjuvant therapy. They should not have received certain recent treatments and must be able to take oral medication and sign consent.

Inclusion Criteria

Patients must have a specific amount of disease that can be measured using a standard method.

Ability to understand and the willingness to sign a written informed consent document

My tumor has a TSC1 or TSC2 mutation, confirmed by a certified lab.

+8 more

Exclusion Criteria

I have not had chemotherapy, immunotherapy, or experimental treatments recently.

I have untreated brain metastases that are causing symptoms.

I am HIV-positive and on combination antiretroviral therapy.

+12 more

Participant Groups

The trial tests Sapanisertib's effectiveness on bladder cancer with TSC1/TSC2 mutations. It's a phase II study to see if the drug can halt tumor growth by inhibiting enzymes needed for cell proliferation. Patients will receive Sapanisertib orally to assess its impact on their disease.

1Treatment groups

Experimental Treatment

Group I: Treatment (sapanisertib)Experimental Treatment1 Intervention

Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.