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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

NCT04817189

Chemotherapy-induced Nausea and Vomiting

COMPLETED PHASE4

Observational Study on the Use of Akynzeo® in Patients Receiving HEC

NCT03649230

Chemotherapy-Induced Nausea and Vomiting

COMPLETED

Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer

NCT06726291

Endometrial Cancer

RECRUITING PHASE4

Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy

NCT06065722

Chemotherapy Induced Nausea and Vomiting

UNKNOWN PHASE2

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer

NCT07169851

Nausea Vomiting Drug-Related Side Effects and Adverse Reactions +1 more

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oncology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AKYNZEO

Group Type EXPERIMENTAL

Akynzeo

Intervention Type 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

Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No