Pemigatinib for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well Pemigatinib, a pill that blocks proteins helping cancer grow, works in patients with bladder cancer that has come back after previous treatment. The drug aims to stop specific proteins needed for cancer growth.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have recently received anti-cancer therapy, radiotherapy, or undergone major surgery, you may need to wait 4 weeks before starting the study drug.
Is pemigatinib safe for humans?
What makes the drug Pemigatinib unique for treating bladder cancer?
What data supports the effectiveness of the drug Pemigatinib for bladder cancer?
Research shows that Pemigatinib, a drug that targets specific genetic changes in cancer cells, has shown antitumor activity in patients with advanced bladder cancer that has certain genetic alterations. This suggests it could be effective for treating bladder cancer with these specific genetic changes.12389
Who Is on the Research Team?
Noah M Hahn, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Are You a Good Fit for This Trial?
This trial is for adults over 18 with recurrent non-muscle invasive bladder cancer that was previously low- or intermediate-risk. They must be able to perform daily activities with little to no assistance (ECOG status 0-2) and have certain lab values within specific ranges. People can't join if they've had recent radiotherapy, surgery, or other cancer treatments, have high-grade urothelial carcinoma in their latest urine test, another active cancer besides some exceptions, or previous treatment with similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pemigatinib for 4-6 weeks prior to standard of care transurethral resection of bladder tumor (TURBT)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of complete response rate and relapse-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Pemigatinib
Pemigatinib is already approved in United States for the following indications:
- Unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement
- Relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School