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AKY15-HK-301_NEPA Study

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

Hong Kong

Study Type

Interventional

Intervention

NEPA

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Clinical Oncology, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEPA

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary

Complete Response during the overall (0-120 h) phase in Cycle 1 by using patient diary

Complete Protection during the acute (0-24 h) phase in Cycle 1 by using patient diary

Complete Protection during the overall (0-120 h) phase in Cycle 1 by using patient diary

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

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

Healthcare resources utilization; The number of hospitalizations will be summarized descriptively

Evaluation of NEPA safety profile; Clinical evaluations for safety assessments will include monitoring AEs

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.

A total FLIE score (expressed in FLIE points) greater than 108 will be categorized as having no impact on daily life

Full Information

NCT ID

NCT03386617

First Posted

November 22, 2017

Last Updated

September 13, 2022

Sponsor

Chinese University of Hong Kong

Collaborators

Princess Margaret Hospital, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03386617

Brief Title

AKY15-HK-301_NEPA Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Princess Margaret Hospital, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NEPA

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

NEPA

Intervention Description

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Complete Response during the acute (0-24 h) phase in Cycle 1 by using patient diary

Time Frame