Post Marketing Surveillance Study for ONIVYDE® in South Korea

The purpose of this study is to characterize the safety of ONIVYDE when used under standard clinical practice in South Korea; and to describe effectiveness in patients receiving ONIVYDE in combination with 5-fluorouracil (5-FU) and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in South Korea.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: ONIVYDE; Drug: 5-fluorouracil; Drug: Leucovorin

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Gyeonggi-do, Korea, Republic of, 10408
    • National Cancer Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System - Gastroenterology
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System - Oncology
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center - Oncology
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St.Mary's Hospital
  • Suwon, Korea, Republic of, 16499
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in South Korea with a diagnosis of metastatic pancreatic cancer.

Description

Inclusion Criteria:

Patients who are prescribed ONIVYDE per investigator's judgment shall be included if:

• Patient / legally authorized representative/ family member gave written informed consent
• Patient is indicated for treatment according to ONIVYDE South Korea prescribing information
• Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
• Documented metastatic disease
• Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy
• Adequate hepatic, renal and hematological function

Exclusion Criteria:

• Patients enrolled in Servier sponsored ONIVYDE Registry or any other Servier sponsored ONIVYDE study
• Patients who have experienced severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL
• Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation of interstitial lung disease. Patients with confirmed diagnosis of interstitial lung disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Study Participants; Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE	Drug: ONIVYDE; irinotecan liposome injection; Drug: 5-fluorouracil; a nucleoside metabolic inhibitor; Other Names: 5-FU; fluorouracil; Drug: Leucovorin; an active metabolite of folic acid; Other Names: LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events (AEs)	Number of AEs by seriousness and severity	Throughout the study period approximately 4 years
Grade 3 and 4 neutropenia cases	Frequency of Grade 3 and 4 neutropenia cases	Throughout the study period approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visit Information: Number of Visit Types	Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits	Throughout the study period approximately 4 years
Visit Information: Reason for Visits	Number of: Scheduled Visits, Emergency Visits, Other Types Visits	Throughout the study period approximately 4 years
Median Dose of ONIVYDE	Median Dose of ONIVYDE administered during the study period	Throughout the study period approximately 4 years
Median Dose of fluorouracil	Median Dose of fluorouracil administered during the study period	Throughout the study period approximately 4 years
Median Dose of Leucovorin	Median Dose of Leucovorin administered during the study period	Throughout the study period approximately 4 years
Overall response	Response duration usually is measured from the time of initial response until documented tumor progression.	Throughout the study period approximately 4 years
Overall Survival	The time from enrollment to death from any cause, is a direct measure of clinical benefit to a patient.	Throughout the study period approximately 4 years
Progression free survival	The time elapsed between treatment initiation and tumor progression or death from any cause.	Throughout the study period approximately 4 years
Quality of Life assessment (EQ-5D-5 L Health Questionnaire)	The instrument that measures conceptual domains of quality of patients' well-being.	Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years

Collaborators and Investigators

• Sponsor: Institut de Recherches Internationales Servier
• Collaborators: ADIR, a Servier Group company

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): August 29, 2020
• Study Completion (Actual): August 29, 2020

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Leucovorin
• Other Study ID Numbers: 331602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: Yes