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Post Marketing Surveillance Study for ONIVYDE® in South Korea

NCT03446872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2021-09-28

No results posted yet for this study

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

DRUG

ONIVYDE

irinotecan liposome injection

DRUG

5-fluorouracil

a nucleoside metabolic inhibitor

DRUG

Leucovorin

an active metabolite of folic acid

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2020-08-29
Completion
2020-08-29
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446872 on ClinicalTrials.gov