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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

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

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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

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DiagnosisRecurrent or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Recurrent or Refractory Malignant Glioma, Recurrent or Refractory Medulloblastoma, Recurrent or Refractory Primary Central Nervous System NeoplasmStudy StatusOpen
PhaseI
Age6 Years to 21 YearsRandomisationN/A
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Savolitinib (Oral) Other Names: AZD 6094 AZD6094 HMPL-504 Volitinib
Last Posted Update2024-02-13
ClinicalTrials.gov #NCT03598244
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

PBTC-049 tests a drug called savolitinib to see how well it works in children with these tumors. This drug has not been studied in children. The hope is that this drug may be a more effective treatment for these types of brain tumors in children.

Therefore, the primary goals of the study are to:

  • Determine which dose of savolitinib is safe for children
  • Learn what effects (good or bad) may occur when patients take savolitinib
  • Learn how the body processes savolitinib

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Inclusion Criteria
  • Patients with confirmed medulloblastoma, high-grade glioma, DIPG brain tumors, and other brain tumor types with a specific genetic marker, which continue to grow or have come back after the prior treatment may be eligible to participate.
  • Patients must be between 5-21 years of age.
  • Patients must have recovered from toxicities of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
  • Pregnant women and nursing mothers are excluded from this study
  • Patients or a parent/guardian must understand and sign a written consent form to participate
  • Patients and/or their families must agree to the study visit requirements outlined in the consent form

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Other inclusion criteria may apply and will be discussed with you by the study team.