Clinical Trials /

Trial of Afatinib in Pediatric Tumours

NCT02372006

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

Related Conditions:
  • Astrocytoma
  • Diffuse Intrinsic Pontine Glioma
  • Ependymoma
  • Malignant Glioma
  • Malignant Solid Tumor
  • Medulloblastoma
  • Neuroblastoma
  • Primitive Neuroectodermal Tumor
  • Rhabdomyosarcoma
Recruiting Status:

Suspended

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 1200.120
  • SECONDARY ID: 2014-002123-10
  • NCT ID: NCT02372006

Conditions

  • Neuroectodermal Tumors
  • Rhabdomyosarcoma

Interventions

DrugSynonymsArms
afatinibafatinib

Purpose

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 Arms

NameTypeDescriptionInterventions
afatinibExperimentaldose escalation
  • afatinib

Eligibility Criteria

        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
      
Maximum Eligible Age:18 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response - expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetics: tmax,ss - dose finding part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: Cmax- dose finding part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: accumulation (or effective) half-life - expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Objective response - dose finding part
Time Frame:up to 2 year
Safety Issue:
Description:
Measure:Progression-free survival - expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: AUC 0-24 - dose finding part
Time Frame:up to 24 hours
Safety Issue:
Description:
Measure:Duration of objective response (DoR) - expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: accumulation (or effective) half-life - dose finding part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: AUCtau,ss expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: Cmax,ss- expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:
Measure:Pharmacokinetics: tmax ,ss- expansion part/Phase II part
Time Frame:up to 2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

Last Updated

December 9, 2019