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.org

Eligibility 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

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