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.

Phase 1

• Conditions: Patients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004686-41-GR
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-24
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

- 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

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified