| Registry | NCT03446872 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 94 (Actual) |
| Sponsor | Institut de Recherches Internationales Servier (Other); collaborators: ADIR, a Servier Group company |
| Conditions | Metastatic Pancreatic Cancer |
| Interventions | ONIVYDE, 5-fluorouracil, Leucovorin (Drug) |
| Dates | start 2018-03-08, primary completion 2020-08-29, completion 2020-08-29, first posted 2018-02-27, last updated 2021-09-28 |
| Locations | 10 sites in South Korea |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| All Study Participants | Drug: ONIVYDE; Drug: 5-fluorouracil; Drug: Leucovorin | Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE |
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Konyang University Hospital | Daejeon | South Korea | |
| National Cancer Center | Gyeonggi-do | South Korea | |
| Severance Hospital, Yonsei University Health System - Gastroenterology | Seoul | South Korea | |
| Severance Hospital, Yonsei University Health System - Oncology | Seoul | South Korea | |
| ASAN Medical Center | Seoul | South Korea | |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | South Korea | |
| Samsung Medical Center - Oncology | Seoul | South Korea | |
| The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | South Korea | |
| Korea University Guro Hospital | Seoul | South Korea | |
| Ajou University Hospital | Suwon | South Korea |