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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR ERDAFITINIB

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All Clinical Trials for Erdafitinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02421185 ↗ Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493 (Erdafitinib) in Participants With Advanced Hepatocellular Carcinoma Recruiting Janssen Research & Development, LLC Phase 1 2015-05-01 The purpose of this study is to determine recommended Phase 2 dose [RP2D]) and the objective response rate of JNJ-42756493 (erdafitinib) in advanced hepatocellular carcinoma (HCC) participants with fibroblast growth factor (FGF) 19 amplification.
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 Recruiting Janssen Research & Development, LLC Phase 2 2016-07-01 The primary purpose of this study is to evaluate objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of erdafitinib in a molecularly-defined subset of Asian participants with non-small-cell lung cancer (NSCLC), urothelial cancer, esophageal cancer and cholangiocarcinoma.
NCT03066687 ↗ A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants Completed Celerion Phase 1 2017-03-14 The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
NCT03066687 ↗ A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants Completed Janssen Research & Development, LLC Phase 1 2017-03-14 The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
NCT03135106 ↗ A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants Recruiting Janssen Research & Development, LLC Phase 1 2017-04-14 The purpose of this study is to evaluate the effect of multiple doses of fluconazole (an inhibitor of cytochrome P450 [CYP] 2C9 and CYP3A) and itraconazole (an inhibitor of CYP3A4 and P-glycoprotein [P-gp]) on the pharmacokinetics of a single 4-milligram (mg) oral dose of erdafitinib in healthy adult participants.
NCT03210714 ↗ Pediatric MATCH: Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR 1/2/3/4 Mutations Not yet recruiting National Cancer Institute (NCI) Phase 2 2017-11-30 This phase II trial studies how well pan-FGFR tyrosine kinase inhibitor JNJ-42756493 works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread to other places in the body and have come back or do not respond to treatment with FGFR 1/2/3/4 mutations. Pan-FGFR tyrosine kinase inhibitor JNJ-42756493 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT03238196 ↗ Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer Not yet recruiting Genentech, Inc. Phase 1 2017-09-01 This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Erdafitinib

Condition Name

Condition Name for Erdafitinib
Intervention Trials
Healthy 3
Castration-Resistant Prostate Carcinoma 2
FGFR3 Gene Mutation 2
Stage IVB Prostate Cancer AJCC v8 2
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Condition MeSH

Condition MeSH for Erdafitinib
Intervention Trials
Carcinoma 4
Urinary Bladder Neoplasms 3
Neoplasms 3
Lung Neoplasms 2
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Clinical Trial Locations for Erdafitinib

Trials by Country

Trials by Country for Erdafitinib
Location Trials
United States 54
Korea, Republic of 6
Belgium 5
China 4
Germany 4
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Trials by US State

Trials by US State for Erdafitinib
Location Trials
New York 6
Texas 5
Pennsylvania 4
California 3
Colorado 3
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Clinical Trial Progress for Erdafitinib

Clinical Trial Phase

Clinical Trial Phase for Erdafitinib
Clinical Trial Phase Trials
Phase 3 1
Phase 2 8
Phase 1/Phase 2 1
[disabled in preview] 8
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Clinical Trial Status

Clinical Trial Status for Erdafitinib
Clinical Trial Phase Trials
Not yet recruiting 11
Recruiting 6
Completed 1
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Clinical Trial Sponsors for Erdafitinib

Sponsor Name

Sponsor Name for Erdafitinib
Sponsor Trials
Janssen Research & Development, LLC 9
National Cancer Institute (NCI) 4
Celerion 1
[disabled in preview] 4
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Sponsor Type

Sponsor Type for Erdafitinib
Sponsor Trials
Industry 13
Other 5
NIH 4
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Serving leading biopharmaceutical companies globally:

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