Observational Study on the Use of Akynzeo® in Patients Receiving HEC
NCT ID: NCT03649230
Last Updated: 2023-08-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
207 participants
OBSERVATIONAL
2018-10-03
2020-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)
NCT04817189
Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV
NCT03008213
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
NCT06726291
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
NCT03403712
Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy
NCT06065722
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
300mg netupitant/0.5mg palonosetron hydrochloride
Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Purdue Pharma, Canada
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jodan Ratz, PhD
Role: STUDY_DIRECTOR
Purdue Pharma, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Montreal, Quebec, Canada
Centre de recherche du CHUS and Hopital Fleurimont
Sherbrooke, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAN-PRO-NEPA-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.