Clinical trial NCT03446872: Post Marketing Surveillance Study for ONIVYDE® in South Korea
Official title: Post Marketing Surveillance Study for ONIVYDE® in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
First posted: 2018-02-27
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in South Korea with a diagnosis of metastatic pancreatic cancer.

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.


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

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: Throughout the study period approximately 4 years
measure: Grade 3 and 4 neutropenia cases
timeFrame: Throughout the study period approximately 4 years
Secondary outcomes:
measure: Visit Information: Number of Visit Types
timeFrame: Throughout the study period approximately 4 years
measure: Visit Information: Reason for Visits
timeFrame: Throughout the study period approximately 4 years
measure: Median Dose of ONIVYDE
timeFrame: Throughout the study period approximately 4 years
measure: Median Dose of fluorouracil
timeFrame: Throughout the study period approximately 4 years
measure: Median Dose of Leucovorin
timeFrame: Throughout the study period approximately 4 years
measure: Overall response
timeFrame: Throughout the study period approximately 4 years
measure: Overall Survival
timeFrame: Throughout the study period approximately 4 years
measure: Progression free survival
timeFrame: Throughout the study period approximately 4 years
measure: Quality of Life assessment (EQ-5D-5 L Health Questionnaire)
timeFrame: Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System - Gastroenterology
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System - Oncology
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - Oncology
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: