Phase I trial of afatinib in pediatric tumours

Phase 1

• Conditions: Paediatric patients with recurrent/refractory high grade glioma (HGG), diffuse intrinsic pontine glioma (DIPG), low grade astrocytoma, neuroblastoma, ependymoma, medulloblastoma/primitive neuroectodermal tumours (PNET), rhabdomyosarcoma (RMS) and/or other solid tumours with known ErbB pathway deregulation regardless of tumour histology; MedDRA version: 17.1Level: LLTClassification code 10029091Term: Neoplasm of unspecified nature of endocrine glands and other parts of nervous systemSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10029006Term: Neoplasm of uncertain behavior of brain and spinal cordSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10029050Term: Neoplasm of uncertain behaviour of connective and other soft tissueSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10028992Term: Neoplasm CNSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002123-10-FR
• Lead Sponsor: Boehringer Ingelheim France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-09
• Study Completion: 2020-08-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 563

Inclusion Criteria

- Paediatric patients
- aged =2 years - <18 years at the time of informed consent
- who present with recurrent/refractory disease after they received at least one prior standard treatment regimen and for whom no effective conventional therapy exists
- Dose finding part: patients with a diagnosis of HGG, DIPG, low grade astrocytoma, neuroblastoma, ependymoma, medulloblastoma/PNET, RMS, and/or solid tumours with known ErbB pathway deregulation regardless of tumour histology.
- MTD expansion cohort: patients with solid tumours (regardless of histology) selected by any biomarker(s) for ErbB pathway deregulation, which was previously identified in a biomarker prevalence study done outside of this clinical trial protocol
-Performance status >= 50% (Lansky for =<12ys; Karnofsky for >12ys)

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-relevant toxicity from previous treatment
-known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified