Sapanisertib for Bladder Cancer

Recruiting at 22 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Corticosteroids, Antiepileptics, PPIs, others

Disqualifiers: CNS metastasis, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 28 days per cycle

17 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain medications like strong inhibitors or inducers of specific enzymes (CYP3A4, CYP2C19, CYP2C9) and proton pump inhibitors. It's best to discuss your current medications with the study team.

What makes the drug Sapanisertib unique for treating bladder cancer?

Sapanisertib is unique because it targets the mTOR pathway, which is involved in cell growth and survival, offering a different mechanism of action compared to traditional chemotherapy and other targeted therapies like tyrosine kinase inhibitors or immune checkpoint inhibitors. This could provide a novel approach for patients with bladder cancer, especially those who do not respond to existing treatments. ^{1 2 3 4 5}

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.

Research Team

Joseph W. Kim, MD

Principal Investigator

Yale University Cancer Center LAO

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sapanisertib orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) and every 6 months thereafter

Treatment Details

Interventions

• Sapanisertib

Trial Overview 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.

Participant Groups

Group I: Treatment (sapanisertib) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The dynamics of the inflammatory response during BBN-induced bladder carcinogenesis in mice. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Pazopanib and sunitinib trigger autophagic and non-autophagic death of bladder tumour cells. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Development of secondary structure, growth characteristics and cytogenetic analysis of human transitional cell carcinoma xenografts in scid/scid mice. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The future of bladder cancer therapy: Optimizing the inhibition of the fibroblast growth factor receptor. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Bladder cancers respond to EGFR inhibitors. [2018]