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

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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


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
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Houston, Texas 77030
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Houston, TX
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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Randwick, New South Wales 2031
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Randwick,
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