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
Study Objectives
1 Primary · 10 Secondary · Reporting Duration: Baseline up to end of study (up to 5 years)
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.
- Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.
- Dosne AG, Valade E, Goeyvaerts N, De Porre P, Avadhani A, O'Hagan A, Li LY, Ouellet D, Perez Ruixo JJ. Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma. Cancer Chemother Pharmacol. 2022 Jan 3. doi: 10.1007/s00280-021-04381-4. [Epub ahead of print]
- Siefker-Radtke AO, Necchi A, Park SH, García-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Jan 11. pii: S1470-2045(21)00660-4. doi: 10.1016/S1470-2045(21)00660-4. [Epub ahead of print]
- Dosne AG, Valade E, Goeyvaerts N, De Porre P, Avadhani A, O'Hagan A, Li LY, Ouellet D, Perez Ruixo JJ. Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma. Cancer Chemother Pharmacol. 2022 Feb;89(2):151-164. doi: 10.1007/s00280-021-04381-4. Epub 2022 Jan 3.
- Siefker-Radtke AO, Necchi A, Park SH, García-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Feb;23(2):248-258. doi: 10.1016/S1470-2045(21)00660-4. Epub 2022 Jan 11.
- Siefker-Radtke AO, Necchi A, Park SH, Garcia-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Feb;23(2):248-258. doi: 10.1016/S1470-2045(21)00660-4. Epub 2022 Jan 11.
- 2015. "An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02365597.
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
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
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
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
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
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