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AKY15-HK-301_NEPA Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03386617
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Princess Margaret Hospital, Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: NEPA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386617


Locations
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Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Princess Margaret Hospital, Hong Kong
Investigators
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Principal Investigator: Winnie Yeo, MD, FRCP Chinese University of Hong Kong

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CCTU, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03386617    
Other Study ID Numbers: SYM011
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents