At a glance
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NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Bone Marrow Aspiration and Biopsy, and 6 other interventions for Advanced Malignant Solid Neoplasm and 32 related conditions. Active but no longer recruiting, targeting 9 participants across 124 sites in 2 countries.
Signals
Detailed Summary
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have come back (relapased) or does not respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Study Details
Timeline
Arms & Interventions
Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.
Interventions
Undergo blood sample collection
Undergo a bone marrow aspiration and/or biopsy
Undergo a bone scan
Undergo a CT scan
Given PO or via nasogastric- or gastric-tube
Undergo MRI
Undergo a MIBG scintigraphy
Undergo an x-ray