EUCTR2014-002123-10-ESActive, not recruitingPhase 1
Phase I open label, dose escalation trial to determine the MTD, safety, PK and efficacy of afatinib monotherapy in children aged 2 years to <18 years with recurrent/refractory neuroectodermal tumours, rhabdomyosarcoma and/or other solid tumours with known ErbB pathway deregulation regardless of tumour histology - Phase I trial of afatinib in pediatric tumours
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 563
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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