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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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ClinicalTrials.gov Identifier: NCT03831633
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
VIFORFRANCE

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
Oncology Drug: Akynzeo Drug: Standard of Care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 19, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Anti-emetic response [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831633


Contacts
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Contact: Stéphane OUARY +33662755802 ext 5802 stephane.ouary@capionis.com

Locations
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France
CHU Avicenne Recruiting
Paris, France
Contact: ZELEK         
Sponsors and Collaborators
VIFORFRANCE

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Responsible Party: VIFORFRANCE
ClinicalTrials.gov Identifier: NCT03831633     History of Changes
Other Study ID Numbers: PRAKYFRA-01
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms