Clinical trial · Observational
Post Marketing Surveillance Study for ONIVYDE® in South Korea
NCT03446872CI-TRIAL-00054114completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| ONIVYDE | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- All Study Participants
- description
- Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
- interventionNames
- Drug: ONIVYDE
- Drug: 5-fluorouracil
- Drug: Leucovorin
Primary outcomes (2)
- measure
- Number of Adverse Events (AEs)
- timeFrame
- Throughout the study period approximately 4 years
- description
- Number of AEs by seriousness and severity
- measure
- Grade 3 and 4 neutropenia cases
- timeFrame
- Throughout the study period approximately 4 years
- description
- Frequency of Grade 3 and 4 neutropenia cases
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.