Trial of Afatinib in Pediatric Tumours

Official Title

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

Summary:

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

Trial Description

Primary Outcome:

  • Objective response - expansion part/Phase II part
  • Dose Limiting Toxicity during first course - dose finding part
  • Pharmacokinetics: AUCtau,ss - dose finding part
  • Pharmacokinetics: Cmax,ss - dose finding part
Secondary Outcome:
  • Pharmacokinetics: tmax,ss - dose finding part
  • Pharmacokinetics: Cmax- dose finding part
  • Pharmacokinetics: accumulation (or effective) half-life - expansion part/Phase II part
  • Objective response - dose finding part
  • Progression-free survival - expansion part/Phase II part
  • Pharmacokinetics: AUC 0-24 - dose finding part
  • Duration of objective response (DoR) - expansion part/Phase II part
  • Pharmacokinetics: accumulation (or effective) half-life - dose finding part
  • Pharmacokinetics: AUCtau,ss expansion part/Phase II part
  • Pharmacokinetics: Cmax,ss- expansion part/Phase II part
  • Pharmacokinetics: tmax ,ss- expansion part/Phase II part

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society