Back to resultsComparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
Primary Purpose
Oncology
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Akynzeo
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Oncology
Eligibility Criteria
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
Sites / Locations
- CHU AvicenneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AKYNZEO
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03831633
Brief Title
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIFORFRANCE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
426 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AKYNZEO
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Akynzeo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Anti-emetic response
Description
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
Time Frame
1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane OUARY
Phone
+33662755802
Ext
5802
Email
stephane.ouary@capionis.com
Facility Information:
Facility Name
CHU Avicenne
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZELEK
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
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