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Clinical Trials/EUCTR2019-004686-41-DE
EUCTR2019-004686-41-DE
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®

Helsinn Healthcare SA0 sites530 target enrollmentStarted: October 23, 2020Last updated:
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DrugsAkynzeo

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
530
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

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
  • •\-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 highly effective 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

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

Similar Trials

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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.Patients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2019-004686-41-CZHelsinn Healthcare SA530
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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.Patients treated with IV moderately emetogenic chemotherapy and at high risk of chemotherapy induced nausea and vomiting (CINV)Therapeutic area: Diseases [C] - Cancer [C04]
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