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)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
- Low Grade Glioma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Malignant Glioma
- Refractory Langerhans Cell Histiocytosis
- Refractory Primary Central Nervous System Neoplasm
- Recurrent Childhood Ependymoma
- Rhabdoid Tumor
- Stage III Soft Tissue Sarcoma AJCC v7
- Refractory Non Hodgkin Lymphoma
- Recurrent Langerhans Cell Histiocytosis
- Wilm's Tumor
- Recurrent Primary Central Nervous System Neoplasm
- Recurrent Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Medulloblastoma
- Recurrent Osteosarcoma
- Recurrent Childhood Non-Hodgkin Lymphoma
- Recurrent Neuroblastoma
- Refractory Malignant Solid Neoplasm
- Stage IV Soft Tissue Sarcoma AJCC v7
- Recurrent Hepatoblastoma
- Recurrent Childhood Rhabdomyosarcoma
- Recurrent Malignant Solid Neoplasm
- Refractory Neuroblastoma
- Recurrent Childhood Soft Tissue Sarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1221 years
- Gender
- Both males and females
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 ha...
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.
Tracking Information
- NCT #
- NCT03210714
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alice Lee Children's Oncology Group