A Study of Avutometinib for People With Solid Tumor Cancers (NCT06104488) | Clinical Trial Compass
RecruitingPhase 1
A Study of Avutometinib for People With Solid Tumor Cancers
United States23 participantsStarted 2023-10-20
Plain-language summary
The purpose of this study is to find out whether avutometinib is a safe treatment for advanced or recurrent solid tumor cancers in children and young adults. Researchers will look for the highest dose of avutometinib that is safe and cause few or mild side effects.
Who can participate
Age range3 Years – 30 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of a pediatric tumor including CNS tumors with activating MAP kinase pathway alterations including but not limited to BRAF/ARAF/CRAF fusions or mutations, KRAS/NRAS/HRAS alterations, PTPN11 or SOS1/2 mutations and/or loss of function alterations in NF1. This will be performed at the enrolling institution and central review is not required OR
✓. Participants with a clinical or molecularly confirmed (germline alteration positive) diagnosis of NF1 with symptomatic inoperable plexiform neurofibromas and recurrent/progressive low-grade gliomas are eligible and may enroll without tissue/biopsy confirmation.
✓. Patients with recurrent optic pathway gliomas are eligible if they have clinical progression (defined as new or worsening neurologic symptoms including visual dysfunction, as defined below):
✓. Anti-cancer agents not known to be myelosuppressive: ≥ 7 days
✓. Anti-cancer and cytotoxic agents known to be myelosuppressive: ≥ 14 days
✓. Immunotherapies (including antibodies, interleukins, interferons, etc.): ≥ 21 days
✓. Adoptive cellular therapies (including modified T cells, vaccines, etc.): ≥ 42 days
✓. Autologous stem cell infusion (boost, no conditioning): ≥ 21 days
Exclusion criteria
✕. Any history of congestive heart failure
✕. Left ventricular ejection fraction (LVEF) \< 50% or below the institutional standard lower limit, whichever is higher, as determined by multiple gated acquisition (MUGA) scan or Trans-thoracic echocardiography (TTE)
✕. QTc \> 470 msec regardless of sex (using Bazett formula) on screening ECG (using triplicate ECGs), history of Torsades de Pointes, or a history of congenital long QT syndrome.