Canadian clinical trial registry

Search results

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.

1 results found

Title
Status

 

E7080-A001-216 ADVL1711 - A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Completed

E7080-A001-216 ADVL1711 - A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Go to Health Care Provider version

DiagnosisHigh Grade Glioma, Ewing sarcoma, RhabdomyosarcomaStudy StatusCompleted
PhaseI/II
AgeChild, Adult - (2 Years to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationOral hard tablets or suspension
Last Posted Update2022-02-14
ClinicalTrials.gov #NCT03245151
International Sponsor
Eisai Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
IWK Health Centre - Dr. Craig Erker
Montreal Children's Hospital - Dr. Sharon Abish



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

 

Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 

 

 

Study Description

This is a study of two medications taken by mouth, called lenvatinib and everolimus. Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive. Everolimus is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. It is called an mTOR inhibitor.

The phase 1 of this study has been completed, and now the phase 2 is on-going to understand the anti-cancer activity of those two medications taken together in patients with Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment.

Inclusion Criteria
  • Age from 2 years to 21 years
  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team