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PBTC-049: A Phase I study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS tumors harboring MET aberrations

Study category: Cancer

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Description

This is a dose escalation study of savolitinib administered orally once a day to patients with recurrent, progressive or refractory central nervous system tumors. There are three stages in this study: a dose escalation cohort, PK expansion cohort, and an efficacy expansion cohort. The dose escalation cohort is designed to determine the maximum tolerated dose (MTD)/recommended Phase II dose (RP2D), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of savolitinib. Once the MTD/RP2D is determined, the enrollment for an efficacy expansion cohort will open for patients whose tumors harbor genetic MET activation as determined by CLIA tests performed at participating sites, and confirmed by FDA approved tests.

Details
Age

Child to Adult

Phase

I - Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants.

Type of Study

Treatment

Location

Childrens Hospital Colorado

Principal Investigator
Kathleen Dorris,  MD

Kathleen Dorris, MD

Study ID

Protocol Number: 18-2432

ClinicalTrials.gov: NCT03598244

Categories

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