Trials / Active Not Recruiting

Active Not RecruitingNCT03210714

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)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Erdafitinib in Patients With Tumors Harboring FGFR1/2/3/4 Alterations

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 20 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 12 Months – 21 Years
Healthy volunteers: Not accepted

Summary

This phase II Pediatric MATCH trial studies how well erdafitinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with FGFR mutations that have spread to other places in the body and have come back or do not respond to treatment. Erdafitinib may stop the growth of cancer cells with FGFR mutations by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with erdafitinib with advanced solid tumors (including central nervous system \[CNS\] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4 pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with erdafitinib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor genetic alterations in the FGFR1/2/3/4. II. To obtain information about the tolerability of erdafitinib in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of erdafitinib in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVE: I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive erdafitinib orally (PO) once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Marrow Aspiration and Biopsy	Undergo a bone marrow aspiration and/or biopsy
PROCEDURE	Bone Scan	Undergo a bone scan
PROCEDURE	Computed Tomography	Undergo a CT scan
DRUG	Erdafitinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
OTHER	Pharmacological Study	Correlative studies
PROCEDURE	Positron Emission Tomography	Undergo a PET scan
PROCEDURE	Radionuclide Imaging	Undergo radionuclide imaging
PROCEDURE	X-Ray Imaging	Undergo an x-ray

Timeline

Start date: 2018-06-05
Primary completion: 2023-09-30
Completion: 2026-12-30
First posted: 2017-07-07
Last updated: 2026-04-01
Results posted: 2024-09-19

Locations

116 sites across 2 countries: United States, Puerto Rico

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03210714. Inclusion in this directory is not an endorsement.