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

Oncology Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03831633
• Other study ID #: PRAKYFRA-01
• Status: Recruiting
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2019
• Source: VIFORFRANCE
• Contact: Stéphane OUARY
• Phone: +33662755802
• Email: stephane.ouary[@]capionis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 426
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oncology
• Vomiting

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Avicenne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
VIFORFRANCE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.