CO40778 (RXDX-101-03)
Research type
Research Study
Full title
A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS WITH LOCALLY ADVANCED OR METASTATIC SOLID OR PRIMARY CNS TUMORS AND/OR WHO HAVE NO SATISFACTORY TREATMENT OPTIONS
IRAS ID
269751
Contact name
Lynley Marshall
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2019-001155-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
8 years, 2 months, 1 days
Research summary
This is a Phase 1/2 multicentre, open-label dose escalation study in paediatric participants with relapsed central nervous system (brain or spinal) tumours and other non-central nervous system solid tumours.
Entrectinib is an investigational new drug designed to target certain changes in cancer cells, which may result in killing of those cells.
This study is divided into a two portions, phase 1 (Part A)- dose escalation (wherein different doses will be tested) and phase 2 (Part B and D) dose expansion(wherein one selected dose will be tested in participants with relapsed or refractory neuroblastoma or in participants whose cancer was previously shown via molecular testing to have specific changes in cancer cells that may be able to be targetable with entrectinib).
The dose escalation part of the study has broader inclusion criteria to test entrectinib in participants with a range of relapsed/refractory solid tumours. In the dose expansion part of the study, participants will be recruited to evaluate tumour response to entrectinib with recommended Phase 2 dose from dose escalation part in their specific type of cancer, with up to 20 participants with central nervous system tumours and 20 participants with other solid tumours.
The study will have a 28-day screening window, which begins once the participant/their legal guardian signs the consent form. The study will then follow cycles of 28 days with oral dosing daily and no treatment breaks. End of Treatment Visit will be within 7 days of the last dose and Safety Follow Up will be 30 days after last dose. Survival Follow-Up will be every 3 months by phone.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1423
Date of REC Opinion
21 Nov 2019
REC opinion
Further Information Favourable Opinion