Trial of Afatinib in Pediatric Tumours

Status:	Recruiting
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	1 - 18
Updated:	4/4/2019
Start Date:	April 29, 2015
End Date:	March 15, 2020
Contact:	Boehringer Ingelheim Call Center
Email:	clintriage.rdg@boehringer-ingelheim.com
Phone:	1-800-243-0127

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

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

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

We found this trial at

sites

Sydney Children's Hospital

Randwick, New South Wales 2031

from

Randwick,