BGJ398 for Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: CYP3A4 modulators, QT prolongers

Disqualifiers: Advanced urothelial carcinoma, GI impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

4 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that you cannot use certain medications like those that increase phosphorus or calcium levels, strong CYP3A4 inducers or inhibitors, and some herbal preparations. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

How does the drug BGJ398 differ from other bladder cancer treatments?

BGJ398 is unique because it specifically targets and inhibits fibroblast growth factor receptors (FGFR1-3), which are often altered in bladder cancer. This oral medication is given in cycles of three weeks on and one week off, and it has shown effectiveness in reducing tumor size and stabilizing the disease in patients with FGFR3 alterations, offering a targeted approach compared to traditional chemotherapy. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer tumors that are confined to the lining of the bladder.

Research Team

Jonathan Rosenberg, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults with recurrent high-risk bladder cancer that hasn't invaded muscle tissue and have had prior BCG therapy. They must be able to take oral meds, perform most daily activities (Karnofsky ≥80), use effective contraception if of childbearing potential, and not have certain health conditions like severe heart disease or active infections.

Inclusion Criteria

Patient willing to consent to MSKCC protocol 12-245 ('Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy')

Women of childbearing potential must agree to use highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment

If a woman is of non-childbearing potential, she must meet specific criteria

Exclusion Criteria

I have not taken amiodarone in the last 90 days.

I am currently taking blood thinners like warfarin.

My liver and kidney functions are not normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BGJ398 at a dose of 125 mg orally once daily on a three weeks on, one week off schedule

7 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGJ398

Trial Overview The trial is testing BGJ398's effectiveness on bladder tumors confined to the lining. It involves patients who've failed previous treatments and have specific genetic changes in their tumors. The study requires adherence to a treatment plan including taking pills and undergoing regular tests.

Participant Groups

Group I: BGJ398 Experimental Treatment 1 Intervention

BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

References

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

Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Inhibitor, in Patients with Previously Treated Advanced Urothelial Carcinoma with FGFR3 Alterations. [2020]

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

Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. [2023]

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

A phase Ib study of BGJ398, a pan-FGFR kinase inhibitor in combination with imatinib in patients with advanced gastrointestinal stromal tumor. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

Radioimmunoimaging of human bladder tumor xenografts in nude mice by using monoclonal antibodies. [2016]

5. Japan pubmed.ncbi.nlm.nih.gov

Human bladder cancer cell-surface antigens recognized by murine monoclonal antibodies raised against T24 bladder cancer cells. [2015]