Post Marketing Surveillance Study for ONIVYDE® in South Korea

Study Overview
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Brief Summary
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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.

Official Title
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Post Marketing Surveillance Study for ONIVYDE® in South Korea

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: ONIVYDE
* Drug: 5-fluorouracil
* Drug: Leucovorin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Study Participants<br>Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE | Drug: ONIVYDE<br>* irinotecan liposome injection<br>Drug: 5-fluorouracil<br>* a nucleoside metabolic inhibitor<br>* Other names: fluorouracil;Drug: Leucovorin<br>* an active metabolite of folic acid<br>* Other names: LV;|

What is the study measuring?
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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 |