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
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
4
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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