Post Marketing Surveillance Study for ONIVYDE® in South Korea

NCT03446872 | Completed FDA Drug

• 1 other identifier: 331602
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 10

Brief 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

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events (AEs)

  Number of AEs by seriousness and severity

  Throughout the study period approximately 4 years

• Grade 3 and 4 neutropenia cases

  Frequency of Grade 3 and 4 neutropenia cases

  Throughout the study period approximately 4 years

Secondary Outcomes (9)

• Visit Information: Number of Visit Types

  Throughout the study period approximately 4 years

• Visit Information: Reason for Visits

  Throughout the study period approximately 4 years

• Median Dose of ONIVYDE

  Throughout the study period approximately 4 years

• Median Dose of fluorouracil

  Throughout the study period approximately 4 years

• Median Dose of Leucovorin

  Throughout the study period approximately 4 years

Study Arms (1)

All Study Participants

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

Drug: ONIVYDE; Drug: 5-fluorouracil; Drug: Leucovorin

Interventions

ONIVYDE DRUG

irinotecan liposome injection

All Study Participants

5-fluorouracil DRUG

a nucleoside metabolic inhibitor

Also known as: 5-FU, fluorouracil

All Study Participants

Leucovorin DRUG

an active metabolite of folic acid

Also known as: LV

All Study Participants

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Internationales Servier: lead
• ADIR, a Servier Group company: collaborator

Study Sites (10)

Konyang University Hospital

Daejeon, 35365, South Korea

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Severance Hospital, Yonsei University Health System - Gastroenterology

Seoul, 03722, South Korea

Location

Severance Hospital, Yonsei University Health System - Oncology

Seoul, 03722, South Korea

Location

ASAN Medical Center

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Samsung Medical Center - Oncology

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 27, 2018
• Study Start: March 8, 2018
• Primary Completion: August 29, 2020
• Study Completion: August 29, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)