Last updated on August 2020

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)


Brief description of study

This phase II Pediatric MATCH trial studies how well erdafitinib 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 mutations. Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with JNJ-42756493 (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 JNJ-42756493 (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 JNJ-42756493 (erdafitinib) in children with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of JNJ-42756493 (erdafitinib) in children with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

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. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Clinical Study Identifier: NCT03210714

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Kaiser Permanente-Oakland

Oakland, CA United States
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Ochsner Medical Center Jefferson

New Orleans, LA United States
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Sinai Hospital of Baltimore

Baltimore, MD United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Children's Hospital Los Angeles

Los Angeles, CA United States
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Yale University

New Haven, CT United States
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Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
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Blank Children's Hospital

Des Moines, IA United States
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Norton Children's Hospital

Louisville, KY United States
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Children's Hospital New Orleans

New Orleans, LA United States
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C S Mott Children's Hospital

Ann Arbor, MI United States
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Saint Peter's University Hospital

New Brunswick, NJ United States
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Geisinger Medical Center

Danville, PA United States
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Cook Children's Medical Center

Fort Worth, TX United States
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Seattle Children's Hospital

Seattle, WA United States
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Primary Children's Hospital

Salt Lake City, UT United States
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M D Anderson Cancer Center

Houston, TX United States
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AdventHealth Orlando

Orlando, FL United States
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Mission Hospital

Asheville, NC United States
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Bronson Methodist Hospital

Kalamazoo, MI United States
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Recruitment Status: Open


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