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Completed

NCT Number: NCT03446872

Post Marketing Surveillance Study for ONIVYDE® in South Korea

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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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konyang University Hospital, Daejeon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONIVYDE

Drug

irinotecan liposome injection

5-fluorouracil

Drug

a nucleoside metabolic inhibitor

Other names: 5-FU, fluorouracil

Leucovorin

Drug

an active metabolite of folic acid

Other names: LV

Primary outcomes

  1. Number of Adverse Events (AEs)

    Time frame: Throughout the study period approximately 4 years

    Number of AEs by seriousness and severity

  2. Grade 3 and 4 neutropenia cases

    Time frame: Throughout the study period approximately 4 years

    Frequency of Grade 3 and 4 neutropenia cases

Secondary outcomes

  1. 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

  2. Visit Information: Reason for Visits

    Time frame: Throughout the study period approximately 4 years

    Number of: Scheduled Visits, Emergency Visits, Other Types Visits

  3. Median Dose of ONIVYDE

    Time frame: Throughout the study period approximately 4 years

    Median Dose of ONIVYDE administered during the study period

  4. Median Dose of fluorouracil

    Time frame: Throughout the study period approximately 4 years

    Median Dose of fluorouracil administered during the study period

  5. Median Dose of Leucovorin

    Time frame: Throughout the study period approximately 4 years

    Median Dose of Leucovorin administered during the study period

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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