Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Glioma
- Advanced Malignant Solid Neoplasm
- Refractory Neuroblastoma
- Recurrent Ependymoma
- Refractory Malignant Glioma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Hepatoblastoma
- Refractory Langerhans Cell Histiocytosis
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Malignant Germ Cell Tumor
- Recurrent Malignant Glioma
- Recurrent Osteosarcoma
- Recurrent Soft Tissue Sarcoma
- Recurrent Rhabdomyosarcoma
- Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Non-Hodgkin Lymphoma
- Refractory Glioma
- Refractory Primary Central Nervous System Neoplasm
- Recurrent Rhabdoid Tumor
- Refractory Rhabdoid Tumor
- Refractory Osteosarcoma
- Refractory Hepatoblastoma
- Refractory Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Refractory Non Hodgkin Lymphoma
- Recurrent Medulloblastoma
- Recurrent Neuroblastoma
- Refractory Ependymoma
- Refractory Rhabdomyosarcoma
- Wilm's Tumor
- Refractory Malignant Germ Cell Tumor
- 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 OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring ...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders harboring NTRK 1/2/3 fusions. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LOXO-101 (larotrectinib) with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders with NTRK 1/2/3 fusions. II. To obtain additional information about the tolerability of LOXO-101 (larotrectinib) in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of LOXO-101 (larotrectinib) 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 larotrectinib sulfate orally (PO) or via nasogastric (NG)- or gastric (G)-tube twice per day (BID) 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 at 30 days, then periodically thereafter.
Tracking Information
- NCT #
- NCT03213704
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Katherine A Janeway Children's Oncology Group
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