Status:
COMPLETED
Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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. Antiemetic guideli...
Detailed Description
Antiemetic guideline recommendations are based on the emetogenic potential of chemotherapy and involve 4 levels of classification of intravenous chemotherapy agents, i.e., high, moderate, low and mini...
Eligibility Criteria
Inclusion
- 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 Eastern Cooperative Oncology Group (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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT04817189
Start Date
February 1 2021
End Date
July 2 2024
Last Update
December 2 2025
Active Locations (19)
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1
Shanghai Chest Hospital
Shanghai, China
2
Shanghai Ninth People´s Hospital
Shanghai, China
3
Shanghai Obstetrics and Gynecology Hospital
Shanghai, China
4
Thomayerova nemocnice
Prague, Czechia, 14059