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
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
- 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.