Efficacy and safety evaluation of oral Akynzeo®
Research type
Research Study
Full title
MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study.
IRAS ID
282483
Contact name
Alessandro Alonzi
Contact email
Sponsor organisation
Helsinn Healthcare SA
Eudract number
2019-004686-41
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
The MyRisk study is a clinical study on drugs which have already received marketing approval by Health Authorities, which means that they are already prescribed to patients by physicians and can be bought at a pharmacy in many countries for use in the prevention of chemotherapy-induced nausea and vomiting (CINV).
Study drugs
- ARM A: Akynzeo® is the fixed combination of netupitant and palonosetron developed by Helsinn Healthcare SA, Switzerland. It is provided in capsules to be taken by mouth. Netupitant and palonosetron act on different receptors in the vomiting area in the brain: it has been demonstrated that when given together the antiemetic efficacy increases.
- ARM B: Standard of care consisting in one of the available 5-HT3 receptor antagonists, which are antiemetics of the same class of palonosetron and recommended by international medical guidelines for the prevention of CINV: they are at this time the most used drugs for Moderately Emetogenic Chemotherapies (MEC).Treatment assignment
Patients agreeing to participate in this Study will be assigned to one of the following:Group 1:
Day 1: Akynzeo® (netupitant 300 mg /palonosetron 0.50 mg) + dexamethasone 8 mg (or equivalent corticosteroids)Group 2:
Day 1: One standard oral dose of one of the available 5-HT3 receptor antagonist (which will be chosen by your Study doctor according to his daily clinical practice) + dexamethasone 8 mg (or equivalent corticosteroids).The determination of which treatment group you are assigned to will be done at random, i.e. like tossing a coin. Your chances of being assigned to either group is equal.
Once assigned to a treatment group before the start of cycle 1, patients will stay on the same treatment group until Study completion.
The Study will be conducted in different countries and different centres, with around 530 patients being recruited.REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/1040
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion