Post Marketing Surveillance Study for ONIVYDE® in South Korea

Metastatic Pancreatic Cancer Clinical Trial

Official title:

Post Marketing Surveillance Study for ONIVYDE® in South Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446872
• Other study ID #: 331602
• Status: Completed
• Start date: March 8, 2018
• Est. completion date: August 29, 2020

Study information

• Verified date: September 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 29, 2020
• Est. primary completion date: August 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer

Intervention

Drug:
• ONIVYDE
irinotecan liposome injection
• 5-fluorouracil
a nucleoside metabolic inhibitor
• Leucovorin
an active metabolite of folic acid

Locations

Country	Name	City	State
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	ASAN Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center - Oncology	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System - Gastroenterology	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System - Oncology	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AEs)	Number of AEs by seriousness and severity	Throughout the study period approximately 4 years
Primary	Grade 3 and 4 neutropenia cases	Frequency of Grade 3 and 4 neutropenia cases	Throughout the study period approximately 4 years
Secondary	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
Secondary	Visit Information: Reason for Visits	Number of: Scheduled Visits, Emergency Visits, Other Types Visits	Throughout the study period approximately 4 years
Secondary	Median Dose of ONIVYDE	Median Dose of ONIVYDE administered during the study period	Throughout the study period approximately 4 years
Secondary	Median Dose of fluorouracil	Median Dose of fluorouracil administered during the study period	Throughout the study period approximately 4 years
Secondary	Median Dose of Leucovorin	Median Dose of Leucovorin administered during the study period	Throughout the study period approximately 4 years
Secondary	Overall response	Response duration usually is measured from the time of initial response until documented tumor progression.	Throughout the study period approximately 4 years
Secondary	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
Secondary	Progression free survival	The time elapsed between treatment initiation and tumor progression or death from any cause.	Throughout the study period approximately 4 years
Secondary	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