Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Histiocytic and Dendritic Cell Neoplasm
- Hematopoietic and Lymphoid Cell Neoplasm
- Recurrent Peripheral Primitive Neuroectodermal Tumor
- Refractory Lymphoma
- Refractory Medulloblastoma
- Recurrent Soft Tissue Sarcoma
- Wilm's Tumor
- Refractory Neuroblastoma
- Refractory Soft Tissue Sarcoma
- Recurrent Ependymoma
- Recurrent Rhabdoid Tumor
- Recurrent WHO Grade II Glioma
- Refractory Rhabdoid Tumor
- Recurrent Neuroblastoma
- Refractory Ewing Sarcoma
- Recurrent Ewing Sarcoma
- Recurrent Hepatoblastoma
- Refractory WHO Grade II Glioma
- Refractory Osteosarcoma
- Refractory Rhabdomyosarcoma
- Refractory Malignant Glioma
- Refractory Malignant Solid Neoplasm
- Refractory Ependymoma
- Refractory Histiocytic and Dendritic Cell Neoplasm
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Non-Hodgkin Lymphoma
- Refractory Hepatoblastoma
- Recurrent Lymphoma
- Recurrent Malignant Germ Cell Tumor
- Recurrent Malignant Glioma
- Recurrent Malignant Solid Neoplasm
- Recurrent Medulloblastoma
- Refractory Peripheral Primitive Neuroectodermal Tumor
- Refractory Langerhans Cell Histiocytosis
- Refractory Malignant Germ Cell Tumor
- Recurrent Osteosarcoma
- Refractory Non Hodgkin Lymphoma
- Recurrent Rhabdomyosarcoma
- 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 selpercatinib (LOXO-292) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with selpercatinib (LOXO-292) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with LOXO-292 with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the RET pathway. II. To obtain information about the tolerability of LOXO-292 in children and adolescents 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 selpercatinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 30 days, then periodically thereafter.
Tracking Information
- NCT #
- NCT04320888
- Collaborators
- Children's Oncology Group
- Investigators
- Principal Investigator: Andrea T Franson Children's Oncology Group
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