Post Marketing Surveillance Study for ONIVYDE® in South Korea
Study Details
Study Description
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 | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | 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:
Drug: Leucovorin
an active metabolite of folic acid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Konyang University Hospital | Daejeon | Korea, Republic of | 35365 | |
| 2 | National Cancer Center | Gyeonggi-do | Korea, Republic of | 10408 | |
| 3 | Severance Hospital, Yonsei University Health System - Gastroenterology | Seoul | Korea, Republic of | 03722 | |
| 4 | Severance Hospital, Yonsei University Health System - Oncology | Seoul | Korea, Republic of | 03722 | |
| 5 | ASAN Medical Center | Seoul | Korea, Republic of | 05505 | |
| 6 | Gangnam Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 06273 | |
| 7 | Samsung Medical Center - Oncology | Seoul | Korea, Republic of | 06351 | |
| 8 | The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 9 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
| 10 | Ajou University Hospital | Suwon | Korea, Republic of | 16499 |
Sponsors and Collaborators
- Institut de Recherches Internationales Servier
- ADIR, a Servier Group company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 331602