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. - Efficacy and safety evaluation of oral Akynzeo®

Helsinn Healthcare SA0 个研究点目标入组 530 人开始时间: 2020年8月24日最近更新: 2020年10月26日

研究概览

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•- Adult patients aged =18 years
•- Patients with a risk score of = 13 as calculated by the algorithm – see 3.6.3.1. Baseline/screening: VISIT 0
•- Signed Informed consent
•- Both sexes
•- Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy
•- Patients with ECOG performance status 0, 1 or 2
•- Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention
•- Naïve and non- naïve to chemotherapy
•- The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records
•- Able to comply with study requirements
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

•-Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy)
•-Patients receiving oral moderately emetogenic chemotherapy drugs
•-Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed)
•-Use of olanzapine as prophylaxis of CINV
•-Patients scheduled to receive radiotherapy concurrently with chemotherapy
•-Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
•-Patients with mechanical risk factors for nausea (i.e. intestinal obstruction)
•-Patients with liver disease (as nausea is a common presenting symptom)
•-Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting)
•-Chronic treatment with steroids (with the exception of inhaled or topical steroids)
•-Pregnancy and/or breast-feeding women
•-Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo®
•-Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV

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