Status:
COMPLETED
Post Marketing Surveillance Study for ONIVYDE® in South Korea
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
19+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 29 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03446872
Start Date
March 8 2018
End Date
August 29 2020
Last Update
September 28 2021
Active Locations (10)
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1
Konyang University Hospital
Daejeon, South Korea, 35365
2
National Cancer Center
Gyeonggi-do, South Korea, 10408
3
Severance Hospital, Yonsei University Health System - Gastroenterology
Seoul, South Korea, 03722
4
Severance Hospital, Yonsei University Health System - Oncology
Seoul, South Korea, 03722