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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

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

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.

The trial will consist of 2 parts:

  1. Dose finding part to determine the MTD
  2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types
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
  • Performance status >= 50% (Lansky for =<12ys; Karnofsky for >12ys)
  • Further inclusion criteria apply
Exclusion Criteria
  • Relevant toxicity from previous treatment
  • Known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
  • Further exclusion criteria apply