Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients

Study Overview
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Brief Summary
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This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting

Official Title
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A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.

Conditions
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Oncology

Intervention / Treatment
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* Drug: Akynzeo
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, Age ≥ 18 years Have a histological or cytological confirmed solid tumor malignancy Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's Naïve of CT ECOG performance up to 2 Able to read, understand and follow the study procedures Patient with Health insurance Exclusion Criteria: Pregnancy and breastfeeding women; Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®; Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AKYNZEO<br> | Drug: Akynzeo<br>* 1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron). - Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4<br>|
| Active Comparator: Standard of Care<br> | Drug: Standard of Care<br>* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3) IV ondansetron 8 mg on Day 1 Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-emetic response | Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen | 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle. |