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

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: NCT03649230
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma, Canada

Study Description
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Brief Summary:
This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).

Condition or disease Intervention/treatment
Chemotherapy-Induced Nausea and Vomiting Drug: 300mg netupitant/0.5mg palonosetron hydrochloride

Detailed Description:
The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
Study Design
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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Real World Observational Study On The Use Of Akynzeo® (Netupitant/Palonosetron) For The Prevention Of Nausea and Vomiting in Oncology Patients Receiving Highly Emetogenic Chemotherapy (HEC) Over Multiple Cycles.
Actual Study Start Date : October 3, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: 300mg netupitant/0.5mg palonosetron hydrochloride
    Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)
    Other Name: Akynzeo®

Outcome Measures
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Primary Outcome Measures :
  1. Total Functional Living Index-Emesis (FLIE) score at cycle 1 [ Time Frame: Day 5 of cycle 1 ]

    The Functional Living Index - Emesis questionnaire is a patient reported outcome (PRO) validated tool with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function.

    Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (where 1= no emesis-7=a great deal).

    Assessed by patient following day 5 of each cycle.



Secondary Outcome Measures :
  1. Complete Response [ Time Frame: daily Day 1-5 ]
    No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)

  2. Severity of Nausea [ Time Frame: daily day 1-5 ]
    Severity of nausea assessed using a Visual Analogue Scale (VAS)

  3. Time to failure [ Time Frame: daily Day 1-5 ]
    time to first emetic episode or time to rescue

  4. incidence of treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: daily though to study completion approximately 6 months ]
    Assessment of patient reported adverse events throughout the observational period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll adult male or female chemotherapy patients of various cancer types who are scheduled to receive chemotherapy with high emetogenic potential for a maximum of 2 days.
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Patient scheduled to receive a highly emetogenic chemotherapy (HEC).
  2. Patient scheduled to receive antiemetic prevention with Akynzeo® according to the approved Canadian Product Monograph as deemed medically necessary by the participating physician independently from this study.
  3. Age ≥ 18 years.
  4. Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®.
  5. Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent prior to or at the screening visit.
  6. Patient is able and willing to comply with the study protocol for the entire length of the study and will follow all study requirements, procedures and complete all visits as required.
  7. Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.

Exclusion Criteria:

  1. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.
  2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®.
  3. Concomitant use of pimozide, terfenadine, astemizole, or cisapride.
  4. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
Contacts and Locations
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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): NCT03649230


Locations
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Sponsors and Collaborators
Purdue Pharma, Canada
Investigators
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Study Director: Jodan Ratz, PhD Purdue Pharma, Canada
More Information
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Responsible Party: Purdue Pharma, Canada
ClinicalTrials.gov Identifier: NCT03649230    
Other Study ID Numbers: CAN-PRO-NEPA-001
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action