EUCTR2019-004686-41-CZ
Active, not recruiting
Phase 1
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®
ConditionsPatients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAkynzeo
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Helsinn Healthcare SA
- Enrollment
- 530
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\-Adult patients aged \=18 years
- •\-Patients with a risk score of \= 13 as calculated by the algorithm (specified in protocol)
- •\-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
- •\-Able to comply with study requirements
- •Are the trial subjects under 18? no
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)
Investigators
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