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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Active Not Recruiting PHASE1 INTERVENTIONAL NCT03598244

Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This phase I trial studies the side effects and best dose of volitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory). Volitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and recommend a phase II dose of volitinib (savolitinib) administered orally daily in children with refractory, progressive or recurrent primary CNS tumors. II. To define and describe the toxicities of savolitinib in children with refractory, progressive, or recurrent primary CNS tumors. III. To characterize the pharmacokinetics of savolitinib in children with refractory, progressive, or recurrent primary CNS tumors. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of savolitinib within the confines of a phase I study. II. To perform a genomic analysis within the confines of a phase I study to investigate correlation between response to treatment (as measured by objective response or progression free survival \[PFS\]) and the presence of specific genomic alterations (e.g., MET or HGF amplification, MET mutations, or MET fusion) and/or specific subgroups of disease. OUTLINE: This is a dose-escalation study of volitinib followed by a dose-expansion study. Patients receive volitinib orally (PO) once daily (QD). Treatment repeats every 28 days for up to 39 courses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection X-ray imaging, and magnetic resonance imaging (MRI) scans throughout study. After completion of study treatment, patients are followed up at 30 days, then periodically for up to 2 years.

Interventions

Name: Biospecimen Collection
Type: PROCEDURE
Description: Undergo blood sample collection
Name: Magnetic Resonance Imaging
Type: PROCEDURE
Description: Undergo MRI scan
Name: Savolitinib
Type: DRUG
Description: Given PO
Name: X-Ray Imaging
Type: PROCEDURE
Description: Undergo X-ray imaging

Primary Outcomes

Measure: Maximum tolerated dose of volitinib
TimeFrame: Up to 30 days post treatment
Description: Will be defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose limiting toxicity and the next higher dose level has been determined to be too toxic.
Measure: Recommend phase II dose
TimeFrame: Up to 30 days post treatment
Description:

Trial Information

NCT ID

NCT03598244

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

National Cancer Institute (NCI)

Last Updated

December 15, 2025