Metastatic Pancreatic Cancer
Conditions
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.
Interventions
DRUGONIVYDE
irinotecan liposome injection
DRUG5-fluorouracil
a nucleoside metabolic inhibitor
DRUGLeucovorin
an active metabolite of folic acid
Sponsors
ADIR, a Servier Group company
Institut de Recherches Internationales Servier
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Median Dose of ONIVYDE | Throughout the study period approximately 4 years | Median Dose of ONIVYDE administered during the study period |
| Median Dose of fluorouracil | Throughout the study period approximately 4 years | Median Dose of fluorouracil administered during the study period |
| Median Dose of Leucovorin | Throughout the study period approximately 4 years | Median Dose of Leucovorin 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 |
| 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. |
| Overall response | Throughout the study period approximately 4 years | Response duration usually is measured from the time of initial response until documented tumor progression. |
| Visit Information: Reason for Visits | Throughout the study period approximately 4 years | Number of: Scheduled Visits, Emergency Visits, Other Types Visits |
Countries
South Korea
Outcome results
None listed