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

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.

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

Study Overview

• Status: Unknown
• Conditions: Oncology
• Intervention / Treatment: Drug: Akynzeo; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Anticipated): 426
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stéphane OUARY; Phone Number: 5802 +33662755802; Email: stephane.ouary@capionis.com

Study Locations

• France
  • Paris, France
    • Recruiting
    • CHU Avicenne
    • Contact: ZELEK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Drug: Standard of Care; 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
Experimental: AKYNZEO	Drug: Akynzeo; 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: VIFORFRANCE

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): July 31, 2019

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: PRAKYFRA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No