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

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

Phase 2

Active, not recruiting

Conditions: Malignant Solid Neoplasm

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Erdafitinib
Procedure: Magnetic Resonance Imaging

First Posted Date: 2024-04-08

Last Posted Date: 2024-10-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06351371

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

Not Applicable

Completed

Conditions: Ovarian Cancer
Steroid Cell Tumor, Malignant

Interventions: Drug: Erdafitinib

First Posted Date: 2024-03-25

Last Posted Date: 2024-03-25

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 1

Registration Number: NCT06328491

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1)

Phase 2

Active, not recruiting

Conditions: Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Erdafitinib
Procedure: Magnetic Resonance Imaging

First Posted Date: 2024-03-13

Last Posted Date: 2024-07-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06308822

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Drug Screening Using IMD in Bladder Cancer

First Posted Date: 2024-01-12

Last Posted Date: 2024-01-12

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 18

Registration Number: NCT06204614

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

Phase 2

Suspended

Conditions: Recurrent Glioblastoma, IDH-Wildtype
Recurrent WHO Grade 2 Glioma
Recurrent WHO Grade 3 Glioma

Interventions: Procedure: Biospecimen Collection
Drug: Erdafitinib
Procedure: Magnetic Resonance Imaging
Procedure: Optical Coherence Tomography

First Posted Date: 2023-05-16

Last Posted Date: 2024-12-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT05859334

Locations: 🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
🇺🇸
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

and more 21 locations

Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial

Phase 2

Withdrawn

Conditions: Bladder Carcinoma
Muscle Invasive Bladder Carcinoma
Renal Pelvis and Ureter Urothelial Carcinoma
Stage IVA Bladder Cancer AJCC v8
Urothelial Carcinoma
Bladder Urothelial Carcinoma
Stage II Bladder Cancer AJCC v8
Stage III Bladder Cancer AJCC v8

Interventions: Biological: Atezolizumab
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Cystoscopy
Drug: Erdafitinib
Procedure: Magnetic Resonance Imaging

First Posted Date: 2022-10-03

Last Posted Date: 2024-03-05

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT05564416

Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib

Terminated

Conditions: Bladder Urothelial Carcinoma
FGFR Mutation
FGFR2 Gene Mutation
Locally Advanced Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Transitional Cell Carcinoma
Platinum-Resistant Urothelial Carcinoma
FGFR3 Gene Mutation
Bladder Cancer
Refractory Bladder Carcinoma

First Posted Date: 2021-09-22

Last Posted Date: 2022-12-22

Lead Sponsor: xCures

Target Recruit Count: 2

Registration Number: NCT05052372

Locations: 🇺🇸
xCures Virtual Site, Raleigh, North Carolina, United States

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

Phase 1

Recruiting

Conditions: Locally Advanced Bladder Urothelial Carcinoma
Locally Advanced Urethral Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Stage IIIB Bladder Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Echocardiography
Drug: Enfortumab Vedotin
Drug: Erdafitinib
Procedure: Multigated Acquisition Scan

First Posted Date: 2021-07-15

Last Posted Date: 2024-12-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT04963153

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCHealth University of Colorado Hospital, Aurora, Colorado, United States

and more 6 locations

A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Bladder Cancer
FGFR3 Gene Mutation
Recurrent Bladder Cancer

Interventions: Drug: Erdafitinib

First Posted Date: 2021-06-08

Last Posted Date: 2024-12-20

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 20

Registration Number: NCT04917809

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Prostate Small Cell Neuroendocrine Carcinoma
Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents
Metastatic Malignant Neoplasm in the Bone
Stage IVB Prostate Cancer AJCC v8
Metastatic Prostate Adenocarcinoma
Castration-Resistant Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Erdafitinib

First Posted Date: 2021-02-15

Last Posted Date: 2024-11-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 11

Registration Number: NCT04754425

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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