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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 17 Aug 2017

At a glance

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

    • 27 Jun 2017 Planned number of patients changed from 60 to 55.
    • 02 May 2017 Planned End Date changed from 12 Jun 2017 to 15 Feb 2019.
    • 02 May 2017 Planned primary completion date changed from 12 Jun 2017 to 15 Feb 2019.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top