Balversa (erdafitinib) / Otsuka, J&J 
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10 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Balversa (erdafitinib) / J&J
THOR, NCT03390504 / 2017-002932-18: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Hourglass May 2019 - Dec 2023 : Regulatory submission in EU in combination with JNJ-63723283 for bladder cancer
Jan 2023 - Dec 2023: Data from THOR trial for advanced urothelial cancer
Active, not recruiting
3
629
Europe, Canada, Japan, US, RoW
Erdafitinib, JNJ-42756493, Vinflunine, Docetaxel, Pembrolizumab, Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Janssen Research & Development, LLC
Urothelial Cancer
09/24
11/26
NCI-2019-03812, NCT03999515: Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

Terminated
2
3
US
Abiraterone Acetate, 154229-18-2, 17-(3-Pyridyl)-5, 16-androstadien-3beta-acetate, Androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, acetate (ester), CB7630, Yonsa, Zytiga, BR9004, BR9004-1, JNJ-212082, Enzalutamide, 915087-33-1, ASP9785, Benzamide, MDV3100, Xtandi, Erdafitinib, Balversa, JNJ-42756493
University of Washington, Janssen Research & Development, LLC
Castration-Resistant Prostate Carcinoma, Double-Negative Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
06/21
06/21
CR108120, NCT02699606: A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

Checkmark Data from BLC2001 trial
Jun 2018 - Jun 2018: Data from BLC2001 trial
Completed
2
35
RoW
Erdafitinib, JNJ-42756493
Janssen Research & Development, LLC
Neoplasm
10/21
03/24
BLC2001, NCT02365597 / 2014-002408-26: An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Checkmark Long term data from BLC2001 study for locally advanced/metastatic urothelial carcinoma
May 2020 - May 2020: Long term data from BLC2001 study for locally advanced/metastatic urothelial carcinoma
Checkmark In the treatment of metastatic urothelial cancer
Jun 2018 - Jun 2018: In the treatment of metastatic urothelial cancer
Active, not recruiting
2
239
Europe, US, RoW
Erdafitinib, JNJ-42756493, Midazolam, Metformin
Janssen Research & Development, LLC
Urothelial Cancer
09/22
12/24
2022-002586-15: Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations and are ineligible for receiving cisplatin treatment Erdafitinib (ERDA) solo o en combinación con cetrelimab (CET) como tratamiento neoadyuvante (antes de la cirugía) en sujetos con cáncer de vejiga músculo-invasivo cuyos tumores expresan alteraciones del gen FGFR y no son elegibles para recibir tratamiento con cisplatino

Not yet recruiting
2
90
Europe
Cetrelimab, Erdafitinib, JNJ-63723283, JNJ-42756493, Solution for infusion, Tablet, Balversa
Spanish Oncology Genito Urinary Group (SOGUG), Spanish Oncology Genitourinary Group (SOGUG), Janssen Pharmaceutica NV
Muscle-invasive bladder cancer (MIBC) Cáncer de vejiga con invasión muscular, Bladder cancer that spreads beyond the inner lining of the bladder and into the muscle layer Cáncer de vejiga que se propaga al musculo grueso, Diseases [C] - Cancer [C04]
 
 
THOR-2, NCT04172675 / 2019-002449-39: A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Active, not recruiting
2
107
Europe, Japan, US, RoW
Erdafitinib, JNJ-42756493, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
Janssen Research & Development, LLC
Urinary Bladder Neoplasms
07/24
03/25
RAGNAR, NCT04083976 / 2019-002113-19: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Jan 2023 - Dec 2023: Data from RAGNAR trial for advanced solid tumors
Checkmark Data from RAGNAR trial for advanced solid tumors and FGFR gene alterations at ASCO 2022
Jun 2022 - Jun 2022: Data from RAGNAR trial for advanced solid tumors and FGFR gene alterations at ASCO 2022
Active, not recruiting
2
316
Europe, Japan, US, RoW
Erdafitinib, JNJ-42756493
Janssen Research & Development, LLC
Advanced Solid Tumor
12/23
09/24
DRUP, NCT02925234 / 2015-004398-33: The Drug Rediscovery Protocol ( Trial)

Recruiting
2
1550
Europe
Panitumumab, Vectibix, Olaparib, Lynparza, Dabrafenib, Tafinlar, Nilotinib, Tasigna, Trametinib, Mekinist, Erlotinib, Tarceva, Trastuzumab and Pertuzumab (combination treatment), Herceptin + Perjeta, Vemurafenib and Cobimetinib (combination treatment), Zelboraf + Cotellic, Vismodegib, Erivedge, Regorafenib, Stivarga, Nivolumab, Opdivo, Afatinib, Giotrif, Dabrafenib and trametinib, Tafinlar and Mekinist, Ribociclib, Kisqali, Lenvatinib, Lenvima, Pembrolizumab, Keytruda, Durvalumab, MEDI4736, Rucaparib, Rubraca, Axitinib, Inlyta, Palbociclib, Ibrance, Crizotinib, Xalkori, Sunitinib, Sutent, Cabozantinib, Cabometyx, Abemaciclib, Verzenios, Alectinib, Alecensa, Atezolizumab and Bevacizumab, Tecentriq and Avastin, Ipilimumab and nivolumab, Yervoy and Opdivo, Entrectinib, Rozlytrek, Talazoparib, Talzenna, Dacomitinib, Vizimpro, Lorlatinib, Lorviqua, Erdafitinib, Balversa, Alpelisib, Piqray, Niraparib, Zejula, Pemigatinib, Pemazyre, Selpercatinib, Retsevmo, Tepotinib, Tepmetko
The Netherlands Cancer Institute, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
Cancer, Tumors, Neoplasm, Neoplasia
09/27
12/27
MyDRUG, NCT03732703: Myeloma-Developing Regimens Using Genomics

Checkmark Data from MyDRUG study for MM at ASH 2022
Dec 2022 - Dec 2022: Data from MyDRUG study for MM at ASH 2022
Recruiting
1/2
228
US
Abemaciclib, dexamethasone, ixazomib, pomalidomide, abemaciclib: Verzenio, LY2835219, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst, Enasidenib, dexamethasone, ixazomib, pomalidomide, enasidenib: AG221, IDHIFA, Cobimetinib, dexamethasone, ixazomib, pomalidomide, cobimetinib: Cotellic, GDC-0973, RG7420, Erdafitinib, dexamethasone, ixazomib, pomalidomide, erdafitinib: G-024, JNJ-42756493, JNJ-493, Venetoclax, dexamethasone, ixazomib, pomalidomide, venetoclax: Venclexta: ABT-199, Daratumumab, dexamethasone, ixazomib, pomalidomide, daratumumab: Darzalex, Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Belantamab mafodotin: BLENREP, GSK2857916, Selinexor, dexamethasone, ixazomib, pomalidomide, Selinexor: XPOVIO
Multiple Myeloma Research Consortium, AbbVie, Celgene Corporation, Eli Lilly and Company, Genentech, Inc., Janssen, LP, Takeda, GlaxoSmithKline, Karyopharm Therapeutics Inc
Relapsed Refractory Multiple Myeloma
02/22
02/24
NORSE, NCT03473743 / 2017-001980-19: A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Checkmark Presenation of data from NORSE trial in combination with cetrelimab for 2L metastatic urothelial carcinoma at ESMO 2021
Sep 2021 - Sep 2021: Presenation of data from NORSE trial in combination with cetrelimab for 2L metastatic urothelial carcinoma at ESMO 2021
Checkmark Presenation of data from NORSE trial in combination with BALVERSA for 2L metastatic urothelial carcinoma at ESMO 2021
Sep 2021 - Sep 2021: Presenation of data from NORSE trial in combination with BALVERSA for 2L metastatic urothelial carcinoma at ESMO 2021
Active, not recruiting
1/2
125
Europe, US, RoW
Erdafitinib, JNJ-42756493, Cetrelimab, JNJ-63723283, Cisplatin, Carboplatin
Janssen Research & Development, LLC
Urothelial Carcinoma
09/22
06/25

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