Post Marketing Surveillance Study for ONIVYDE® in South Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-08

Study Completion Date

2020-08-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Study Participants

Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE

ONIVYDE

Intervention Type DRUG

irinotecan liposome injection

5-fluorouracil

Intervention Type DRUG

a nucleoside metabolic inhibitor

Leucovorin

Intervention Type DRUG

an active metabolite of folic acid

Interventions

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ONIVYDE

irinotecan liposome injection

Intervention Type DRUG

5-fluorouracil

a nucleoside metabolic inhibitor

Intervention Type DRUG

Leucovorin

an active metabolite of folic acid

Intervention Type DRUG

Other Intervention Names

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5-FU fluorouracil LV

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No