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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 )

Tracking Information
First Submitted Date February 12, 2018
First Posted Date February 27, 2018
Last Update Posted Date May 23, 2019
Actual Study Start Date March 8, 2018
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2018)
  • Number of Adverse Events (AEs) [ Time Frame: Throughout the study period approximately 4 years ]
    Number of AEs by seriousness and severity
  • Grade 3 and 4 neutropenia cases [ Time Frame: Throughout the study period approximately 4 years ]
    Frequency of Grade 3 and 4 neutropenia cases
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03446872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 22, 2019)
  • 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
  • Visit Information: Reason for Visits [ Time Frame: Throughout the study period approximately 4 years ]
    Number of: Scheduled Visits, Emergency Visits, Other Types Visits
  • Median Dose of ONIVYDE [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of ONIVYDE administered during the study period
  • Median Dose of fluorouracil [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of fluorouracil administered during the study period
  • Median Dose of Leucovorin [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of Leucovorin administered during the study period
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: February 23, 2018)
  • 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
  • Visit Information: Reason for Visits [ Time Frame: Throughout the study period approximately 4 years ]
    Number of: Scheduled Visits, Emergency Visits, Other Types Visits
  • Median Dose of ONIVYADE [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of ONIVYADE administered during the study period
  • Median Dose of fluorouracil [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of fluorouracil administered during the study period
  • Median Dose of Leucovorin [ Time Frame: Throughout the study period approximately 4 years ]
    Median Dose of Leucovorin administered during the study period
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Study for ONIVYDE® in South Korea
Official Title Post Marketing Surveillance Study for ONIVYDE® in South Korea
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients in South Korea with a diagnosis of metastatic pancreatic cancer.
Condition Metastatic Pancreatic Cancer
Intervention
  • 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
Study Groups/Cohorts All Study Participants
Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE
Interventions:
  • Drug: ONIVYDE
  • Drug: 5-fluorouracil
  • Drug: Leucovorin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 23, 2018)
78
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Institut de Recherches Internationales Servier Clinical Studies Department +33 1 55 72 43 66 clinicaltrials@servier.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03446872
Other Study ID Numbers 331602
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Servier ( Institut de Recherches Internationales Servier )
Study Sponsor Institut de Recherches Internationales Servier
Collaborators Not Provided
Investigators Not Provided
PRS Account Servier
Verification Date May 2019