At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 56 enrolled
Drug / intervention
afatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating afatinib for Neuroectodermal Tumors and Rhabdomyosarcoma. Completed, enrolled 56 participants across 28 sites in 12 countries.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroectodermal Tumors, Rhabdomyosarcoma
CountriesAustralia, Austria, Canada, Denmark, Faroe Islands, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartApr 2015
Primary CompletionAug 2020
TodayJul 2026
First PostedFeb 26, 2015
Enrollment StartApr 29, 2015
Primary CompletionAug 5, 2020
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 11.3 years ago
Interventions
afatinibdrug