Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

• Status: Recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

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 guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential.

In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics:

1. nausea and/or vomiting in the prior cycle of chemotherapy

2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy

3. platinum or anthracycline-based chemotherapy

4. age < 60 years

5. expectations for (anticipating) nausea and/or vomiting

6. <7 h of sleep the night before chemotherapy

7. history of morning sickness during previous pregnancy

8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward).

The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinn Healthcare SA
• Treatments: Dexamethasone; Dolasetron; Granisetron; Ondansetron; Palonosetron; Tropisetron

Criteria

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 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 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