Erdafitinib for Bladder Cancer

Phase-Based Progress Estimates
NCT02365597, Charlotte, NCBladder CancerErdafitinib - Drug
All Sexes
What conditions do you have?

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Baseline up to end of study (up to 5 years)

Year 5
Percentage of Participants With Biomarker Assessment
Plasma Clearance of Erdafitinib
Plasma Concentration of Erdafitinib
Volume of Distribution of Erdafitinib
Year 5
Overall survival
Year 5
Duration of Response
Progression-free survival
Year 1
Percentage of Participants with Best Overall Response
Year 5
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 14 days
Plasma Concentration of Midazolam and its Metabolite (1-OH-midazolam)
Up to 15 days
Plasma Concentration of Metformin

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Erdafitinib (8 milligram)
1 of 1

Experimental Treatment

255 Total Participants · 1 Treatment Group

Primary Treatment: Erdafitinib · No Placebo Group · Phase 2

Erdafitinib (8 milligram)Experimental Group · 3 Interventions: Midazolam, Metformin, Erdafitinib · Intervention Types: Drug, Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to end of study (up to 5 years)

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
934 Previous Clinical Trials
6,368,976 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
717 Previous Clinical Trials
3,951,117 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.