Status:
ACTIVE_NOT_RECRUITING
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
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 facto...
Detailed Description
Erdafitinib is a selective and potent pan FGFR 1-4 inhibitor with demonstrated clinical activity in participants with metastatic urothelial cancer and cholangiocarcinoma identified to have alterations...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04083976
Start Date
November 20 2019
End Date
December 31 2026
Last Update
December 23 2025
Active Locations (171)
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1
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85711
2
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80907
3
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
4
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256