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

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.

Sponsors

Lead Sponsor: Purdue Pharma, Canada

Source Purdue Pharma, Canada
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).

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).

Overall Status Completed
Start Date October 3, 2018
Completion Date January 30, 2020
Primary Completion Date December 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Total Functional Living Index-Emesis (FLIE) score at cycle 1 Day 5 of cycle 1
Secondary Outcome
Measure Time Frame
Complete Response daily Day 1-5
Severity of Nausea daily day 1-5
Time to failure daily Day 1-5
incidence of treatment-Emergent Adverse Events [Safety and Tolerability] daily though to study completion approximately 6 months
Enrollment 207
Condition
Intervention

Intervention Type: Drug

Intervention Name: 300mg netupitant/0.5mg palonosetron hydrochloride

Description: Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)

Other Name: Akynzeo®

Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jodan Ratz, PhD Study Director Purdue Pharma, Canada
Location
Facility:
Tom Baker Cancer Center | Calgary, Alberta, Canada
The Moncton Hospital | Moncton, New Brunswick, Canada
NSHA-QEII Health Sciences Centre | Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre | Sydney, Nova Scotia, Canada
Royal Victoria Regional Health Centre | Barrie, Ontario, Canada
William Osler Health System | Brampton, Ontario, Canada
Grand River Regional Cancer Centre | Kitchener, Ontario, Canada
London Health Sciences Centre | London, Ontario, Canada
Thunder Bay Regional Health Sciences Centre | Thunder Bay, Ontario, Canada
St. Michael's Hospital | Toronto, Ontario, Canada
Sunnybrook Health Sciences Center | Toronto, Ontario, Canada
Windsor Regional Cancer Centre | Windsor, Ontario, Canada
Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre | Greenfield Park, Quebec, Canada
Cisss de Chaudiere-Appalaches | Lévis, Quebec, Canada
Segal Cancer Centre-Jewish General Hospital | Montréal, Quebec, Canada
Centre de recherche du CHUS and Hopital Fleurimont | Sherbrooke, Quebec, Canada
Saskatoon Cancer Centre | Saskatoon, Saskatchewan, Canada
Location Countries

Canada

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym EVOLVE_CINV
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov