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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

NCT03831633 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2019-02-06

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • VIFORFRANCE

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831633 on ClinicalTrials.gov