Post Marketing Surveillance Study for ONIVYDE® in South Korea

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
All Study Participants	5-fluorouracil	Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
All Study Participants	ONIVYDE	Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
All Study Participants	Leucovorin	Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (10): Konyang University Hospital
🇰🇷
Daejeon, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
ASAN Medical Center
🇰🇷
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System - Gastroenterology
🇰🇷
Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System - Oncology
🇰🇷
Seoul, Korea, Republic of
National Cancer Center
🇰🇷
Gyeonggi-do, Korea, Republic of
Samsung Medical Center - Oncology
🇰🇷
Seoul, Korea, Republic of
The Catholic University of Korea Seoul St.Mary's Hospital
🇰🇷
Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷
Suwon, Korea, Republic of