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
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials