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Post Marketing Surveillance Study for ONIVYDE® in South Korea

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ClinicalTrials.gov Identifier: NCT03446872
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

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.

Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer Drug: ONIVYDE Drug: 5-fluorouracil Drug: Leucovorin

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Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study for ONIVYDE® in South Korea
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Name: LV




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in South Korea with a diagnosis of metastatic pancreatic cancer.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446872


Contacts
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Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinicaltrials@servier.com

Locations
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Korea, Republic of
Konyang University Hospital Recruiting
Daejeon, Korea, Republic of, 35365
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
Severance Hospital, Yonsei University Health System - Gastroenterology Recruiting
Seoul, Korea, Republic of, 03722
Severance Hospital, Yonsei University Health System - Oncology Recruiting
Seoul, Korea, Republic of, 03722
Gangnam Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 06273
Samsung Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 16499
Sponsors and Collaborators
Institut de Recherches Internationales Servier

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT03446872     History of Changes
Other Study ID Numbers: 331602
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Fluorouracil
Camptothecin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors