A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Completed · Phase 2

Conditions studied: Advanced Solid Tumor

In brief

The purpose of this study is to evaluate the efficacy of erdafitinib in terms of overall response rate (ORR) in adult and pediatric participants with advanced solid tumors with fibroblast growth factor receptor (FGFR) alterations (mutations or gene fusions). It will also evaluate ORR in pediatric participants with advanced solid tumors and FGFR alterations.

Key facts

Study ID

NCT04083976

Run by

Janssen Research & Development, LLC

People needed

316

Starts

2019-11-20

Expected to finish

2026-02-28

Last updated by the study team

2026-05-04

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic demonstration of an unresectable, locally advanced, or metastatic solid tumor malignancy with an fibroblast growth factor receptor (FGFR) mutation or FGFR gene fusion
• Measurable disease
• Participant must have received at least one prior line of systemic therapy in the advanced, unresectable, or metastatic setting; or is a child or adolescent participant with a newly-diagnosed solid tumor and no acceptable standard therapies
• Documented progression of disease, defined as any progression that requires a change in treatment, prior to full study screening

You may not qualify if…

• Has had prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 15 days or less than or equal to (<=) 5 half-lives of the agent (whichever is longer) and up to a maximum of 30 days before the first dose of erdafitinib
• The presence of FGFR gatekeeper and resistance mutations
• Histologic demonstration of urothelial carcinoma
• Hematologic malignancy (i.e., myeloid and lymphoid neoplasms
• For non-small cell lung cancer participants only: pathogenic somatic mutations or gene fusions in the following genes: EGFR, ALK, ROS1, NTRK, BRAF V600E and KRAS
• Active malignancies other than for disease requiring therapy

Where it is running

• Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Hawaii Cancer Care — ‘Aiea, Hawaii, United States
• Maine Medical Center — Scarborough, Maine, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mount Sinai — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology, PLLC — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology Baylor Charles A Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology-Fort Worth Cancer Center — Fort Worth, Texas, United States
• MD Anderson — Houston, Texas, United States
• Oncology Consultants Texas — Houston, Texas, United States
• Texas Oncology Odessa-West Texas Cancer Center — Odessa, Texas, United States
• Texas Oncology San Antonio Northeast — San Antonio, Texas, United States
• Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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