Trial of Afatinib in Pediatric Tumours

Boehringer Ingelheim

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rhabdomyosarcoma; Neuroectodermal Tumors

Treatments: Drug: afatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02372006

1200.120

2014-002123-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

afatinib

Experimental group

Description:

dose escalation

Treatment:

Drug: afatinib