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Active Not RecruitingNCT04320888

Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients With Tumors Harboring RET Gene Alterations

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
1 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
12 Months – 21 Years
Healthy volunteers
Not accepted

Summary

This phase II pediatric MATCH treatment trial studies how well selpercatinib works in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), lymphomas, or histiocytic disorders that have activating RET gene alterations. Selpercatinib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway (called the RET pathway) and may reduce tumor size.

Detailed 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 genetic alterations in the RET pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with selpercatinib (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 selpercatinib (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 on study. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial. After completion of study treatment, patients are followed for 30 days, then periodically thereafter.

Conditions

Interventions

TypeNameDescription
PROCEDUREComputed TomographyUndergo CT, PET/CT, and/or CT/MRI
PROCEDUREMagnetic Resonance ImagingUndergo MRI, PET/MRI, and/or CT/MRI
PROCEDUREPositron Emission TomographyUndergo PET, PET/CT, and/or PET/MRI
PROCEDURERadionuclide ImagingUndergo scintigraphy
DRUGSelpercatinibGiven PO
PROCEDUREX-Ray ImagingUndergo x-ray imaging

Timeline

Start date
2021-05-03
Primary completion
2024-09-30
Completion
2026-06-30
First posted
2020-03-25
Last updated
2025-12-04
Results posted
2025-11-06

Locations

174 sites across 3 countries: United States, Australia, Puerto Rico

Regulatory

Source: ClinicalTrials.gov record NCT04320888. Inclusion in this directory is not an endorsement.