1200.120 Phase I monotherapy basket trial of afatinib in children.
Research type
Research Study
Full title
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.
IRAS ID
161395
Contact name
Darren Hargrave
Contact email
Eudract number
2014-002123-10
Duration of Study in the UK
0 years, 1 months, 10 days
Research summary
This is a Phase I, open-label study to determine the Maximum Tolerated Dose (MTD) of afatinib as single agent and to assess its anti-tumour activity in children with recurrent or refractory malignant neuroectodermal tumours, Rhabdomyosarcomas and other solid tumours with known ErbB pathway deregulations regardless of tumour histology.
The clinical trial itself has 2 parts:
1. A dose finding part which is a rolling 6 design which will require approximately 30 patients.
2. A MTD expansion cohort which will require approximately 20 patients who will be selected by any biomarker for ErbB deregulation.It is planned to recruit 60 patients into the study, to allow for 50 of them to be evaluable. The trial will end when the last patient has completed the 28-30 days safety follow-up (FU) visit.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/0605
Date of REC Opinion
2 Jun 2015
REC opinion
Further Information Favourable Opinion