Phase I Trial of Afatinib in Pediatric Tumours
Status: Recruiting
Phase:
DFCI Protocol ID: 15-315
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort to assess clinical anti-tumour activity in included tumour types
Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute
Overall PI:
Mark Kieran, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.orgEligibility Criteria
Inclusion criteria:
- Paediatric patients aged 2 years 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)
Exclusion criteria:
- relevant toxicity from previous treatment
- known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD,
keratitis