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

NCT03831633 | Unknown Phase 4

• 1 other identifier: PRAKYFRA-01
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

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

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

AKYNZEO

EXPERIMENTAL

Drug: Akynzeo

Standard of Care

ACTIVE COMPARATOR

Drug: Standard of Care

Interventions

Akynzeo DRUG

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

AKYNZEO

Standard of Care DRUG

* 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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VIFORFRANCE: lead

Study Sites (1)

CHU Avicenne

Paris, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

netupitant, palosentron drug combination; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Stéphane OUARY

CONTACT

+33662755802; stephane.ouary@capionis.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 6, 2019
• Study Start: September 19, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)