CRISP
Research type
Research Study
Full title
A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies
IRAS ID
241002
Contact name
Lynley Marshall
Contact email
Sponsor organisation
Erasmus Medical Center
Eudract number
2015-005437-53
Clinicaltrials.gov Identifier
NTR 5584, Dutch Trial Regsietr
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
The current prognosis for patients with the relapsed or refractory diseases being investigated is poor. There is an urgent need to improve therapeutic options for children and adolescents with high risk cancers and to develop less toxic treatment options.
Crizotinib is one such potential treatment option. It can help slow down tumour growth or shrink tumours when specific genetic changes are found in a tumour. The genetic changes can be tested for and as a group are called biomarkers or targets.
Patients will be included in 3 separate groups (also called Strata):
Group 1 –relapsed/refractory anaplastic large cell lymphoma (ALCL) patients with ALK-aberrations will receive crizotinib in combination with vinblastine. We will look for a safe dose of these drugs in combination, then assess how well the combination works in this disease; it is hoped that combining crizotinib with vinblastine will improve outcome.
Group 2 – relapsed/refractory neuroblastoma (NBL) and rhabdomyosarcoma (RMS) patients with ALK- or MET-aberrations will be given crizotinib with temsirolimus. We will look for a safe dose of these drugs in combination and then to assess how well the combination works. It has been shown in laboratory studies that adding temsirolimus may increase the benefit of crizotinib in these diseases.
Group 3 – patients with inflammatory myofibroblastic tumours (IMT) or other tumours with ALK-, MET- or ROS1 mutations who have no other known curative treatment options, will be given crizotinib in order to assess the safety and potential benefit of the drug in these diseases.
This is an international trial led by the Erasmus Medical Center in The Netherlands and managed by the Cancer Research UK Clinical Trials Unit (CRTCU) at the University of Birmingham) . The trial will open at 7 sites in the UK and will open internationally in the UK, The Netherlands, Spain, Denmark, Ireland, Italy, France and Germany.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1743
Date of REC Opinion
12 Nov 2019
REC opinion
Favourable Opinion