Post Marketing Surveillance Study for ONIVYDE® in South Korea

September 27, 2021 updated by: Institut de Recherches Internationales Servier
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System - Gastroenterology
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System - Oncology
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center - Oncology
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St.Mary's Hospital
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in South Korea with a diagnosis of metastatic pancreatic cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All Study Participants
Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
Drug: ONIVYDE
irinotecan liposome injection
Drug: 5-fluorouracil
a nucleoside metabolic inhibitor
Other Names:
  • 5-FU
  • fluorouracil
Drug: Leucovorin
an active metabolite of folic acid
Other Names:
  • LV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs)
Time Frame: Throughout the study period approximately 4 years
Number of AEs by seriousness and severity
Throughout the study period approximately 4 years
Grade 3 and 4 neutropenia cases
Time Frame: Throughout the study period approximately 4 years
Frequency of Grade 3 and 4 neutropenia cases
Throughout the study period approximately 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visit Information: Number of Visit Types
Time Frame: Throughout the study period approximately 4 years
Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits
Throughout the study period approximately 4 years
Visit Information: Reason for Visits
Time Frame: Throughout the study period approximately 4 years
Number of: Scheduled Visits, Emergency Visits, Other Types Visits
Throughout the study period approximately 4 years
Median Dose of ONIVYDE
Time Frame: Throughout the study period approximately 4 years
Median Dose of ONIVYDE administered during the study period
Throughout the study period approximately 4 years
Median Dose of fluorouracil
Time Frame: Throughout the study period approximately 4 years
Median Dose of fluorouracil administered during the study period
Throughout the study period approximately 4 years
Median Dose of Leucovorin
Time Frame: Throughout the study period approximately 4 years
Median Dose of Leucovorin administered during the study period
Throughout the study period approximately 4 years
Overall response
Time Frame: Throughout the study period approximately 4 years
Response duration usually is measured from the time of initial response until documented tumor progression.
Throughout the study period approximately 4 years
Overall Survival
Time Frame: Throughout the study period approximately 4 years
The time from enrollment to death from any cause, is a direct measure of clinical benefit to a patient.
Throughout the study period approximately 4 years
Progression free survival
Time Frame: Throughout the study period approximately 4 years
The time elapsed between treatment initiation and tumor progression or death from any cause.
Throughout the study period approximately 4 years
Quality of Life assessment (EQ-5D-5 L Health Questionnaire)
Time Frame: Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years
The instrument that measures conceptual domains of quality of patients' well-being.
Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherches Internationales Servier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ADIR, a Servier Group company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 331602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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