AKY15-HK-301_NEPA Study

March 2, 2026 updated by: CCTU, Chinese University of Hong Kong

Open Label Single Arm Study for NEPA [Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron] in Hong Kong Oncology Patients Receiving (Neo)-Adjuvant Chemotherapy Treatment Consists of Adriamycin and Cyclophosphamide for Breast Cancer

Nausea and vomiting (feeling sick to your stomach and throwing up) are two of the most common unpleasant side effects of chemotherapy agents (drugs specifically used to treat cancer) that will be used for cancer treatment. If nausea and vomiting are not controlled, they could lead to dehydration, poor nutrition and a longer time in the hospital. Nausea and vomiting usually occur in response to conditions that affect the gut and the vomiting center, which is an area in the brain.

Netupitant and palonosetron are drugs that are thought to block the activation of certain types of chemicals in these areas (brain and gut) and, therefore, to prevent or reduce the severity of nausea and vomiting. Nausea and vomiting caused by chemotherapy is classified into two patterns based on the time of onset or start. Acute nausea and vomiting start within 24 hours of chemotherapy administration. Delayed nausea and vomiting starts approximately 2-5 days after chemotherapy administration. Regardless of when the nausea and vomiting start, these symptoms are usually treated with not just one drug, but a combination of drugs. In this study you will receive the study drug, which is a fixed combination of netupitant and palonosetron.

This is an open label single arm study. The main purpose of this study or clinical trial is to learn more about the effect (how well it works) of the fixed combination of netupitant and palonosetron (NEPA) in preventing nausea and vomiting associated with chemotherapy in Hong Kong oncology patients receiving (neo)-adjuvant chemotherapy treatment consists of adriamycin and cyclophosphamide for breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients ( ≥ 18 and <75 years), female; a. Chinese patient, female ≥18 and < 75 years of age.
  • Patient is diagnosed with early breast cancer.
  • Patient is scheduled to receive her first course of (neo)- adjuvant chemotherapy for breast cancer follows:
  • IV adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2
  • ECOG Performance Status of 0-1;
  • Written informed consent before study entry;
  • If women of childbearing potential age: reliable contraceptive measures are to be used during all the planned course of the study;
  • Ability and willingness of the patient to complete the diary and study questionnaires.

Exclusion Criteria:

  • Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study;
  • Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy;
  • Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy;
  • Patients who have taken any of the following agents within 7 calendar days prior to initiation of their chemotherapy regimen: 5-HT3 receptor antagonists, phenothiazines, benzamides, cannabinoids, NK1 receptor antagonists, corticosteroids, or benzodiazepines;
  • Pregnant or breast-feeding women;
  • Patient's inability to take oral medication;
  • Gastrointestinal obstruction or active peptic ulcer;
  • Psychiatric or CNS disorders interfering with ability to comply with study protocol;
  • Patients at risk for severe cardiac/cardiovascular disorders
  • Patients with myocardial infarction within 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NEPA

Day 1 of each chemotherapy cycle:

1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.
Drug: NEPA

Day 1 of each chemotherapy cycle:

1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the proportion of patients with a Complete Response (CR), during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Time Frame: up to 84 days
up to 84 days
To evaluate the proportion of patients with Complete Protection during the delayed phase (24-120 h post-chemotherapy) periods in cycle 1 by using patient diary
Time Frame: up to 84 days
up to 84 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Response during the overall (0-120 h) phase in Cycle 1 by using patient diary
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the acute (0-24 h) phase in Cycle 1 by using patient diary
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Complete Protection during the overall (0-120 h) phase in Cycle 1 by using patient diary
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during the acute delayed phase in cycle 1 will be summarized descriptively
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Total Control during the acute, delayed and overall phases of Cycle 1; The percentage of patients with Total Control during overall phase in cycle 1 will be summarized descriptively
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Healthcare resources utilization; The number of hospitalizations will be summarized descriptively
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
Evaluation of NEPA safety profile; Clinical evaluations for safety assessments will include monitoring AEs
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
To assess the impact of nausea and vomiting on patients' quality of life, the FILE (Functional Living Index-Emesis) with a 5-day recall will be used.
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
A total FLIE score (expressed in FLIE points) greater than 108 will be categorized as having no impact on daily life
Time Frame: 6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days
6 days for every 3 weekly cycles. total 4 cycles, so time frame is 84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Princess Margaret Hospital, Hong Kong

Investigators

  • Principal Investigator: Winnie Yeo, MD, FRCP, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

December 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYM011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on NEPA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe