Post Marketing Surveillance Study For ONIVYDE® In South Korea

Study Overview

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.

N/A

Metastatic Pancreatic Cancer

DRUG: ONIVYDE
DRUG: 5-fluorouracil
DRUG: Leucovorin

331602

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-09-27
First Submitted that Met QC Criteria 2018-02-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-09-28
First Posted (ACTUAL) 2018-02-27	Results First Posted N/A	Last Verified 2021-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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 DRUG: Leucovorin an active metabolite of folic acid

Participant Group/Arm

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

DRUG: Leucovorin

an active metabolite of folic acid

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

ADIR, a Servier Group company

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record