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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

 

1200.120 - Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

Closed to enrollment

More information

1200.120 - Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

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DiagnosisNeuroectodermal Tumors, Rhabdomyosarcoma, CNS tumors, Other brain tumours, Other solid tumors, PNET, Tumour with Erb pathway deregulationStudy StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (1 Year to 18 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationOral
Last Posted Update2022-04-25
ClinicalTrials.gov #NCT02372006
International Sponsor
Boehringer Ingelheim
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

Some solid tumours and some brain tumours shares common a common feature that is called "deregulation of the ErbB-pathway". Afatinib is an drug, taken by mouth, that can block proteins from the ErbB-family and could be efficient in pediatric tumours with Erb pathway deregulation. 

The aim of this study is to find the maximum tolerated dose of afatinib, and to assess its activity against tumours.

Inclusion Criteria
  • Paediatric patients aged 1 year to <18 years at the time of informed consent
  • Diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
  • Recurrent/refractory disease after they received at least one prior standard treatment regimen
  • No effective conventional therapy exists

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.