Trials / Completed
CompletedNCT03446872
Post Marketing Surveillance Study for ONIVYDE® in South Korea
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 94 (actual)
- Sponsor
- Institut de Recherches Internationales Servier · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONIVYDE | irinotecan liposome injection |
| DRUG | 5-fluorouracil | a nucleoside metabolic inhibitor |
| DRUG | Leucovorin | an active metabolite of folic acid |
Timeline
- Start date
- 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 across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03446872. Inclusion in this directory is not an endorsement.