Clincosm LogoSign in Get a demo

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

Sponsor
VIFORFRANCE (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03831633
Collaborator
(none)
426
Enrollment
1
Location
2
Arms
10.3
Anticipated Duration (Months)
41.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
426 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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.
Actual Study Start Date :
Sep 19, 2018
Anticipated Primary Completion Date :
Jul 31, 2019
Anticipated Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

  1. Anti-emetic response [1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Avicenne Paris France

Sponsors and Collaborators

  • VIFORFRANCE

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VIFORFRANCE
ClinicalTrials.gov Identifier:
NCT03831633
Other Study ID Numbers:
  • PRAKYFRA-01
First Posted:
Feb 6, 2019
Last Update Posted:
Feb 6, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vomiting

Study Results

No Results Posted as of Feb 6, 2019