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Tyrosine Kinase Inhibitor
Oral Erdafitinib for Bladder Cancer
Phase 2
Recruiting
Led By Eugene Pietzak, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Genetic testing of the participant's prior or recurrent NMIBC tumor will be performed to confirm the presence of an FGFR3 mutation
Participants must have NMIBC that has come back after prior treatment (instillations of BCG or chemotherapy into the bladder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks after first study treatment
Awards & highlights
Study Summary
This trial is testing whether a drug called erdafitinib can shrink tumors in people with a certain type of bladder cancer.
Who is the study for?
This trial is for adults with non-muscle invasive bladder cancer that has returned after treatments like BCG or chemo. Participants must have a specific FGFR3 gene mutation in their tumor, be able to perform daily activities, and have good organ function. Pregnant women, those with muscle-invasive or metastatic bladder cancer, and individuals on certain medications are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of erdafitinib, an oral medication targeting a protein from the altered FGFR3 gene which may halt cancer cell growth. It's given to patients whose recurrent bladder tumors show this genetic change before they undergo surgery to remove the tumor.See study design
What are the potential side effects?
Erdafitinib can cause side effects such as dry mouth or skin changes; nail problems; high phosphate levels leading to muscle cramps or weakness; eye issues like dry eyes or blurred vision; and less commonly liver problems, hair loss, tiredness, stomach pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder cancer has an FGFR3 mutation.
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My bladder cancer returned after initial treatments.
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I can walk and do my daily activities for most of the day.
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I am able to get out of my bed or chair and move around.
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You need to have normal bone marrow, liver, and kidney function. This means having a certain level of white blood cells, platelets, and hemoglobin in your blood, and having normal liver and kidney test results. If you're a woman who can have children, you need to use birth control during the study. If you're a man, you need to use contraception during and for a few months after the study.
Select...
My cancer has a specific FGFR3 mutation or gene fusion.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks after first study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks after first study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with FGFR3-mutant or -fusion noninvasive bladder tumorsExperimental Treatment1 Intervention
25 participants with FGFR3-mutant or -fusion noninvasive bladder tumors will be accrued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erdafitinib
2017
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,830 Total Patients Enrolled
Eugene Pietzak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a specific FGFR inhibitor before.I have a bleeding or clotting disorder.I have or am being treated for advanced bladder cancer.I can stop taking certain medications before starting treatment with erdafitinib.My bladder cancer has an FGFR3 mutation.I do not have stomach or bowel problems that could affect how a medicine is absorbed.My bladder cancer has returned despite previous treatment.I am 18 years old or older.My bladder cancer returned after initial treatments.I can walk and do my daily activities for most of the day.I am able to get out of my bed or chair and move around.You need to have normal bone marrow, liver, and kidney function. This means having a certain level of white blood cells, platelets, and hemoglobin in your blood, and having normal liver and kidney test results. If you're a woman who can have children, you need to use birth control during the study. If you're a man, you need to use contraception during and for a few months after the study.I haven't had a heart attack or unstable angina in the last 3 months and don't have severe heart failure.My cancer has spread to areas like the urethra, ureter, or kidney.I haven't had immunotherapy in the last 30 days and have no severe side effects from it.I am currently receiving or scheduled for radiation for bladder cancer, or I've had radiation for another cancer but not bladder cancer.I have a diagnosed eye condition affecting my cornea or retina.My cancer is in the earliest stage, not spread beyond the original site.I can stop taking my calcium, vitamin D, or other related supplements for the study.I have difficulty making decisions due to my health condition.I haven't had cancer treatment within the last 30 days or 5 half-lives of the treatment.I have not had a stroke or mini-stroke in the last 3 months.I have a condition affecting my body's calcium or phosphate levels.My bladder cancer did not respond to BCG treatment.My cancer has a specific FGFR3 mutation or gene fusion.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with FGFR3-mutant or -fusion noninvasive bladder tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this project taking on new participants?
"As per the information on clinicaltrials.gov, this medical trial is currently in search of participants. The trial was originally posted on February 17th 2022 and has been updated as recently as August 22nd 2022."
Answered by AI
Have there been any prior experiments involving Erdafitinib?
"Currently, 15 clinical trials are underway that explore the efficacy of Erdafitinib. One of these studies is in its third phase; while most of them are located in Almelo and Utrecht cities, globally there are 3,013 sites where this medication can be studied."
Answered by AI
How many participants have enrolled in this experiment?
"Affirmative. Reports on clinicaltrials.gov indicate that this medical study, which was first advertised on February 17th 2022, is actively recruiting participants from 7 different research sites - 25 subjects in total are required for the trial to proceed as planned."
Answered by AI
In what geographic regions is this clinical trial available?
"At present, 7 sites are running the trial in cities such as Basking Ridge, Uniondale and Harrison. For convenience's sake, it is best to select a site closest to you if participating."
Answered by AI
Has Erdafitinib been granted regulatory approval by the FDA?
"As Erdafitinib is only in its second phase of clinical trials, our team at Power gave it a safety rating of 2. This score denotes that there are some data points demonstrating the medication's security but none indicating efficacy."
Answered by AI
Has this type of trial ever been attempted before?
"Since 2015, research into the efficacy of erdafitinib has been ongoing. Initially sponsored by Janssen Research & Development, LLC., an initial trial involving 255 participants was conducted in 2015 and Phase 2 drug approval followed shortly after. Currently, 37 countries across 903 cities are participating in 15 active trials for this medication."
Answered by AI
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