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| Diagnosis | Neuroectodermal Tumors, Rhabdomyosarcoma, CNS tumors, Other brain tumours, Other solid tumors, PNET, Tumour with Erb pathway deregulation | Study Status | Closed to enrollment |
| Phase | I/II |
| Age | Child, Adult - (1 Year to 18 Years) | Randomisation | NO |
| Line of treatment | First line treatment, Disease relapse or progression |
| Routes of Treatment Administration | Oral |
| Last Posted Update | 2022-04-25 |
| ClinicalTrials.gov # | NCT02372006 |
International Sponsor
Boehringer IngelheimPrincipal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Vijay RamaswamyCentres
Study Description
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.
The trial will consist of 2 parts:
- Dose finding part to determine the MTD
- 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
