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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 26 May 2023

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At a glance

  • Drugs Afatinib (Primary)
  • Indications Astrocytoma; Ependymoma; Glioma; Medulloblastoma; Neuroblastoma; Neuroectodermal tumours; Rhabdomyosarcoma; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 20 Apr 2023 Results assessing the safety, pharmacokinetics and preliminary antitumor activity of afatinib in paediatric patients with cancer published in the European Journal of Cancer
    • 27 Aug 2020 Status changed from active, no longer recruiting to completed.
    • 21 Aug 2020 This trial has been completed in Germany, according to European Clinical Trials Database record.
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