EUCTR2014-002123-10-ATActive, not recruitingPhase 1
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 - Phase I/II trial of afatinib in pediatric tumours
Boehringer Ingelheim RCV GmbH & Co KG0 sites55 target enrollmentStarted: February 19, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 55
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 =1 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: cohorts/Phase II part: Patients with HGG, DIPG, EM and other solid tumours than aforementioned which fulfil at least two of the below criteria:
- •o EGFR gene amplification (FISH): Either EGFR/Cen7 = 2.0 or =10% of cells with =15 copies or =40% of cells with = 4 copies or gene cluster in =10% of cells and/or
- •o HER2 gene amplification (DDISH): Her2/CEP17 = 2.0 and/or
- •o EGFR protein expression: H-score > 150 (membrane staining) and/or
- •o HER2 protein expression: H-score > 0 (membrane staining)
- •Inclusion will be based on biomarker assessment prior to inclusion, as detected by central laboratory analysis of tumour biopsy materia -
- •Patients with proven genomic, transcriptomic or proteomic ErbB alterations which are not defined in the above regardless of tumour histology
- •-Performance status >= 50% (Lansky for =<12ys; Karnofsky for >12ys)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 55
- •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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