Erdafitinib

Generic Name: Erdafitinib

Brand Names: Balversa

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₀N_₆O_₂

CAS Number: 1346242-81-6

Unique Ingredient Identifier: 890E37NHMV

Background: In early April of 2019, the US FDA approved Janssen Pharmaceutical Companies' brand name Balversa (erdafitinib) as the first-ever fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or followin...

Indication: Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor that is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations and has progressed during or following at least one line of prior platinum-containing chemotherapy includ...

Associated Conditions: Locally Advanced or Metastatic Urothelial Carcinoma (UC)

Associated Therapies: -

Clinical Trials

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Erdafitinib
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2017-08-03

Last Posted Date: 2024-11-14

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 35

Registration Number: NCT03238196

Locations: 🇺🇸
Baptist Memorial Hospital MEMPHIS, Memphis, Tennessee, United States
🇺🇸
University of Alabama, Birmingham, Alabama, United States
🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 3 locations

Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

First Posted Date: 2017-07-07

Last Posted Date: 2024-10-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT03210714

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 113 locations

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Phase 2

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Juvenile Xanthogranuloma
Langerhans Cell Histiocytosis
Malignant Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Recurrent Primary Central Nervous System Neoplasm
Refractory Hepatoblastoma
Refractory Medulloblastoma

First Posted Date: 2017-05-16

Last Posted Date: 2024-12-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2316

Registration Number: NCT03155620

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
East Carolina University, Greenville, North Carolina, United States
🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

and more 169 locations

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Erdafitinib
Drug: Fluconazole
Drug: Itraconazole

First Posted Date: 2017-05-01

Last Posted Date: 2017-09-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 54

Registration Number: NCT03135106

Locations: 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium

A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Erdafitinib

First Posted Date: 2017-02-28

Last Posted Date: 2017-06-23

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 16

Registration Number: NCT03066687

Locations: 🇺🇸
Celerion, Lincoln, Nebraska, United States

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date: 2016-10-05

Last Posted Date: 2024-01-24

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 1550

Registration Number: NCT02925234

Locations: 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

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

Phase 2

Completed

Conditions: Neoplasm

Interventions: Drug: Erdafitinib

First Posted Date: 2016-03-04

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 35

Registration Number: NCT02699606

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Capivasertib
Drug: Binimetinib
Drug: Adavosertib
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Afatinib Dimaleate
Drug: Dabrafenib
Drug: Defactinib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: Taselisib
Drug: Sapanisertib
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Ulixertinib
Biological: Trastuzumab Emtansine
Drug: Copanlisib Hydrochloride
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Drug: Larotrectinib Sulfate
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸
Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States

and more 1416 locations

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Phase 2

Active, not recruiting

Conditions: Urothelial Cancer

Interventions: Drug: Erdafitinib
Drug: Midazolam
Drug: Metformin

First Posted Date: 2015-02-19

Last Posted Date: 2024-12-05

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 239

Registration Number: NCT02365597

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