Metastatic Pancreatic CancerNCT03446872
Post Marketing Surveillance Study for ONIVYDE® in South Korea
An observational study of Metastatic Pancreatic Cancer, run by Institut de Recherches Internationales Servier at 10 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- ONIVYDE, 5-fluorouracil and Leucovorin
- Type of treatment
- Injection or infusion
- How many people
- 94 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 8 Mar 2018to 29 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in South Korea with a diagnosis of metastatic pancreatic cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Konyang University Hospital
Daejeon, 35365
National Cancer Center
Gyeonggi-do, 10408
Severance Hospital, Yonsei University Health System - Gastroenterology
Seoul, 03722
Severance Hospital, Yonsei University Health System - Oncology
Seoul, 03722
ASAN Medical Center
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Samsung Medical Center - Oncology
Seoul, 06351
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591
Korea University Guro Hospital
Seoul, 08308
Ajou University Hospital
Suwon, 16499
About this study
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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- ONIVYDE, 5-fluorouracil, Leucovorin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONIVYDEDrug
irinotecan liposome injection
5-fluorouracilDrug
Also called 5-FU, fluorouracil
a nucleoside metabolic inhibitor
LeucovorinDrug
Also called LV
an active metabolite of folic acid
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE Receives: Drug: ONIVYDE; Drug: 5-fluorouracil; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Number of AEs by seriousness and severity
Measured: Throughout the study period approximately 4 years
Grade 3 and 4 neutropenia cases
Frequency of Grade 3 and 4 neutropenia cases
Measured: Throughout the study period approximately 4 years
Secondary outcomes (9)
Visit Information: Number of Visit Types
Number of: Outpatient/office Visits, In-hospital Visits, Phone Visits, or Other Types Visits
Measured: Throughout the study period approximately 4 years
Visit Information: Reason for Visits
Number of: Scheduled Visits, Emergency Visits, Other Types Visits
Measured: Throughout the study period approximately 4 years
Median Dose of ONIVYDE
Median Dose of ONIVYDE administered during the study period
Measured: Throughout the study period approximately 4 years
Median Dose of fluorouracil
Median Dose of fluorouracil administered during the study period
Measured: Throughout the study period approximately 4 years
Median Dose of Leucovorin
Median Dose of Leucovorin administered during the study period
Measured: Throughout the study period approximately 4 years
Overall response
Response duration usually is measured from the time of initial response until documented tumor progression.
Measured: Throughout the study period approximately 4 years
Overall Survival
The time from enrollment to death from any cause, is a direct measure of clinical benefit to a patient.
Measured: Throughout the study period approximately 4 years
Progression free survival
The time elapsed between treatment initiation and tumor progression or death from any cause.
Measured: Throughout the study period approximately 4 years
Quality of Life assessment (EQ-5D-5 L Health Questionnaire)
The instrument that measures conceptual domains of quality of patients' well-being.
Measured: Baseline, and then every 3 weeks, and at the end of study visit up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start8 Mar 2018
- Primary completion29 Aug 2020
- Study completion29 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446872
- Sponsor's protocol ID
- 331602
- Status last verified
- Sep 2021
- First submitted
- 12 Feb 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study for ONIVYDE® in South Korea
- ClinicalTrials.gov ID
- NCT03446872
- Acronym / sponsor ID
- 331602
- Conditions
- Metastatic Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 29 Aug 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | – | Drug: ONIVYDE, Drug: 5-fluorouracil, Drug: LeucovorinPatients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in South Korea with a diagnosis of metastatic pancreatic cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONIVYDEirinotecan liposome injection | Drug | All Study Participants |
| 5-fluorouracilAlso: 5-FU, fluorouracila nucleoside metabolic inhibitor | Drug | All Study Participants |
| LeucovorinAlso: LVan active metabolite of folic acid | Drug | All Study Participants |
Primary outcome
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
9 secondary outcomes
Visit Information: Number of Visit Types
Time frame: Throughout the study period approximately 4 years
Visit Information: Reason for Visits
Time frame: Throughout the study period approximately 4 years
Median Dose of ONIVYDE
Time frame: Throughout the study period approximately 4 years
Median Dose of fluorouracil
Time frame: Throughout the study period approximately 4 years
Median Dose of Leucovorin
Time frame: Throughout the study period approximately 4 years
Overall response
Time frame: Throughout the study period approximately 4 years
Overall Survival
Time frame: Throughout the study period approximately 4 years
Progression free survival
Time frame: Throughout the study period approximately 4 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Pancreatic Cancer, run by Institut de Recherches Internationales Servier at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) (time frame: Throughout the study period approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.