Trial of Afatinib in Pediatric Tumours

• Status: Completed
• Trial end date: 2020-08-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Afatinib

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