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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effects of BGJ398 on bladder cancer confined to the bladder lining. BGJ398 is administered as a pill in cycles of three weeks on, one week off. The trial aims to evaluate the drug's effectiveness on tumors in individuals with high-risk, non-muscle-invasive bladder cancer, particularly after treatments like BCG therapy. Candidates with recurrent bladder cancer, specific genetic markers, and prior BCG therapy may be suitable participants. Participants should be able to take oral medication and commit to regular check-ups and tests. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in bladder cancer treatment.

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.

Is there any evidence suggesting that BGJ398 is likely to be safe for humans?

Research has shown that BGJ398 is generally safe and manageable for treating cancer. Patients who took BGJ398 experienced side effects, but doctors managed them effectively. These side effects did not hinder the treatment's ability to work against tumors. The treatment controlled cancer effectively, with some patients even seeing their tumors shrink.

In another study, BGJ398 showed moderate effectiveness against cancer, and its side effects were manageable. While some side effects occurred, they were not too severe for most patients. Overall, the safety evidence appears promising for those considering joining a trial with BGJ398. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BGJ398 for bladder cancer because it targets the FGFR (fibroblast growth factor receptor) pathway, which is a new approach compared to standard chemotherapy and immunotherapy options. Unlike traditional treatments, BGJ398 is taken orally, offering a more convenient administration method. This drug specifically inhibits the FGFR pathways that are often involved in cancer cell growth, making it a promising option for patients with FGFR genetic alterations.

What evidence suggests that BGJ398 might be an effective treatment for bladder cancer?

Research has shown that BGJ398, also known as infigratinib, is a promising treatment for certain bladder cancers. This drug blocks specific proteins called FGFR1–3, which often promote cancer cell growth. In a study with patients who had similar types of cancer, about 25% experienced tumor shrinkage. Additionally, about 39% had stable disease, meaning their cancer did not worsen. These results suggest that BGJ398 could effectively treat bladder cancer confined to the bladder lining. Participants in this trial will receive BGJ398 at a dose of 125 mg orally once daily on a three-weeks-on, one-week-off schedule. ^{3 6 7 8 9}

Who Is on the Research Team?

Jonathan Rosenberg, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7515773/

Infigratinib in Upper Tract Urothelial Carcinoma Versus ... Infigratinib (BGJ398) is a potent and selective fibroblast grown factor receptor 1 to 3 (FGFR1–3) inhibitor with significant activity in patients with advanced ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.629

Infigratinib versus placebo in patients with resected ... We examine infigratinib, a potent and selective inhibitor of FGFR3, as adjuvant therapy in patients with high-risk resected UC.

3. aacrjournals.org aacrjournals.org/cancerdiscovery/article/8/7/812/10057/Efficacy-of-BGJ398-a-Fibroblast-Growth-Factor

Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1–3 ... The primary endpoint was the response rate. Among 67 patients treated, an overall response rate of 25.4% was observed and an additional 38.8% of patients had ...

4. urotoday.com urotoday.com/conference-highlights/asco-2023/asco-2023-bladder-cancer/144884-asco-2023-fgfr3-alterations-in-proof-302-a-phase-iii-trial-of-infigratinib-bgj398-as-adjuvant-therapy-in-patients-with-invasive-urothelial-carcinoma.html

ASCO 2023: FGFR3 Alterations in PROOF 302: A Phase III ... PROOF 302 is a global, randomized, double-blind, placebo-controlled, phase III trial for patients with high-risk invasive upper tract urothelial carcinoma.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34782263/

Infigratinib in Early-Line and Salvage Therapy for FGFR3 ... Thirteen of 59 patients with a bladder primary tumor received early-line treatment with an ORR of 30.5% (95% CI 9.1-61.4), and 46 received ≥2 LOT with an ORR of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6865065/

Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1 ... BGJ398 at the MTD/RP2D had a tolerable and manageable safety profile and showed antitumor activity in several tumor types, including FGFR1-amplified sqNSCLC and ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.4517

Efficacy of BGJ398, a fibroblast growth factor receptor ... Most responses were observed after 2 treatment cycles. Of 7 pts with stable disease, 6 had tumor reductions ranging from 10%-26%. Safety was ...

8. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(21)00196-5/abstract

Infigratinib (BGJ398) in previously treated patients with ... Infigratinib has promising clinical activity and a manageable adverse event profile in previously treated patients with locally advanced or ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S030573722300021X

Role of FGFR3 in bladder cancer: Treatment landscape ... Indeed, the five-year survival rate drops dramatically from 70% in patients with localized disease to 38% and 6% in locally advanced and metastatic urothelial ...