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Post Marketing Surveillance Study for ONIVYDE® in South Korea

NCT03446872 — Completed, 94 participants, Institut de Recherches Internationales Servier

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RegistryNCT03446872
StatusCompleted
Study typeObservational
Enrollment94 (Actual)
SponsorInstitut de Recherches Internationales Servier (Other); collaborators: ADIR, a Servier Group company
ConditionsMetastatic Pancreatic Cancer
InterventionsONIVYDE, 5-fluorouracil, Leucovorin (Drug)
Datesstart 2018-03-08, primary completion 2020-08-29, completion 2020-08-29, first posted 2018-02-27, last updated 2021-09-28
Locations10 sites in South Korea

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
All Study ParticipantsDrug: ONIVYDE; Drug: 5-fluorouracil; Drug: LeucovorinPatients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
  • ONIVYDE (Drug): irinotecan liposome injection
  • 5-fluorouracil (Drug), also known as 5-FU, fluorouracil: a nucleoside metabolic inhibitor
  • Leucovorin (Drug), also known as LV: an active metabolite of folic acid

+Outcome measures

Primary outcomes

  • Number of Adverse Events (AEs) [Throughout the study period approximately 4 years]: Number of AEs by seriousness and severity
  • Grade 3 and 4 neutropenia cases [Throughout the study period approximately 4 years]: Frequency of Grade 3 and 4 neutropenia cases

Secondary outcomes

  • Visit Information: Number of Visit Types [Throughout the study period approximately 4 years]: Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits
  • Visit Information: Reason for Visits [Throughout the study period approximately 4 years]: Number of: Scheduled Visits, Emergency Visits, Other Types Visits
  • Median Dose of ONIVYDE [Throughout the study period approximately 4 years]: Median Dose of ONIVYDE administered during the study period
  • Median Dose of fluorouracil [Throughout the study period approximately 4 years]: Median Dose of fluorouracil administered during the study period
  • Median Dose of Leucovorin [Throughout the study period approximately 4 years]: Median Dose of Leucovorin administered during the study period
  • Overall response [Throughout the study period approximately 4 years]: Response duration usually is measured from the time of initial response until documented tumor progression.
  • Overall Survival [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.
  • Progression free survival [Throughout the study period approximately 4 years]: The time elapsed between treatment initiation and tumor progression or death from any cause.
  • Quality of Life assessment (EQ-5D-5 L Health Questionnaire) [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.

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (10)

FacilityCityCountryStatus
Konyang University HospitalDaejeonSouth Korea
National Cancer CenterGyeonggi-doSouth Korea
Severance Hospital, Yonsei University Health System - GastroenterologySeoulSouth Korea
Severance Hospital, Yonsei University Health System - OncologySeoulSouth Korea
ASAN Medical CenterSeoulSouth Korea
Gangnam Severance Hospital, Yonsei University Health SystemSeoulSouth Korea
Samsung Medical Center - OncologySeoulSouth Korea
The Catholic University of Korea Seoul St.Mary's HospitalSeoulSouth Korea
Korea University Guro HospitalSeoulSouth Korea
Ajou University HospitalSuwonSouth Korea

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