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Tyrosine Kinase Inhibitor

Erdafitinib for Bladder Cancer

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to 6 years 2 months
Awards & highlights

Study Summary

This trial will test a new treatment for cancer that has spread or can't be removed by surgery, and that has a specific genetic change.

Who is the study for?
This trial is for adults with advanced bladder cancer that can't be removed by surgery or has spread, and who have already tried chemotherapy without success. They should be able to perform daily activities with minimal assistance (ECOG score 0-2) and have normal organ function. Women must not be pregnant and agree to contraception.Check my eligibility
What is being tested?
The study tests Erdafitinib's effectiveness in shrinking or eliminating tumors in patients with specific genetic changes in their cancer cells. It also looks at how the body processes the drug when taken with Midazolam or Metformin.See study design
What are the potential side effects?
Erdafitinib may cause high phosphate levels, mouth sores, nail problems, skin rash, tiredness, change in hair color, diarrhea, dry mouth/skin/eyes, loss of appetite, altered taste sensation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to 6 years 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 6 years 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Metformin Alone or in Combination With Erdafitinib
Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Infinite Time (AUC[0-Infinity]) of Midazolam Alone or in Combination With Erdafitinib
+10 more
Secondary outcome measures
Main Study: Duration of Response (DoR)
Main Study: Overall Survival
Main Study: Percentage of Participants With Treatment-emergent Adverse Event (TEAEs)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Erdafitinib (8 milligram)Experimental Treatment3 Interventions
Prior to interim analysis 1 (IA1), there were 2 treatment regimens: Regimen 1 (10 milligram [mg] once daily, 7 days on/7 days off); and Regimen 2 (6 mg once daily for 28 days). Following IA1, Regimen 1 is closed for further enrollment and starting dose of Regimen 2 is increased to 8 mg once daily for 28 days on a 28-day cycle (referred to as Regimen 3). Participants who enrolled in DDI substudy will receive pretreatment with single doses of midazolam (Day -2) and metformin (Day -1). Participants enrolled in DDI substudy will receive 8 mg erdafitinib treatment from Day 1 to Day 15, single doses of midazolam 2.5 mg (Day 13) and metformin 1000 mg (Day 14) and erdafitinib treatment will continued until disease progression. Participants who completed the DDI substudy and continue to benefit from erdafitinib treatment, will continue to receive erdafitinib in long-term extension (LTE) phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
Metformin
2006
Completed Phase 4
~2430
Erdafitinib
2017
Completed Phase 1
~110

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,483 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,669 Total Patients Enrolled

Media Library

Erdafitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02365597 — Phase 2
Bladder Cancer Research Study Groups: Erdafitinib (8 milligram)
Bladder Cancer Clinical Trial 2023: Erdafitinib Highlights & Side Effects. Trial Name: NCT02365597 — Phase 2
Erdafitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02365597 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant cap for this research trial?

"Unfortunately, this clinical trial is no longer recruiting. It was initially posted on April 22nd 2015 and the last update was November 9th 2022. However, if you are still interested in finding a study to participate in there are 32 trials looking for patients with urothelial cancer and 248 studies enrolling participants that use erdafitinib."

Answered by AI

For what medical purposes is Erdafitinib typically prescribed?

"Erdafitinib can help to mitigate anxiolysis, as well as inadequate response to metformin, status epilepticus (convulsive), and other anxiety-related therapies."

Answered by AI

How many locations in this state are currently conducting the research trial?

"This medical trial is occupying 27 different sites, situated in Las Vegas, Charlotte and Houston along with 24 other areas. It would be beneficial to choose the closest site available to you so as to reduce travel-related pressures when participating."

Answered by AI

Does this research endeavor presently have any openings for participants?

"At present, this trial is not enrolling patients. Originally launched on April 22nd 2015 and last updated November 9th 2022, prospective participants may want to investigate the 32 studies looking for urothelial cancer sufferers or even the 248 Erdafitinib trials actively recruiting."

Answered by AI

What other research efforts have been undertaken in regards to Erdafitinib?

"As of now, 248 medical assessments are underway with regards to Erdafitinib and 54 of those trials have reached Phase 3. Despite the fact that many locations for these investigations are in Porto Alegre and Iowa, more than 5000 research sites globally are using Erdafitinib as part of their clinical studies."

Answered by AI

What potential risks should individuals be aware of when taking Erdafitinib?

"Erdafitinib was granted a safety rating of 2, as there is some data confirming its security but no evidence backing up the efficiency of this drug."

Answered by AI
~24 spots leftby Mar 2025