Metastatic Pancreatic CancerSEOPACNCT06688240
A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
An observational study of Metastatic Pancreatic Cancer, run by Servier (Tianjin) Pharmaceutical Co. LTD..
Trial summary
The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland. Primary objective To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: 1. Quantify the rate of grade ≥3 neutropenia (primary objective) 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For a margin of error of 10% and to adjust for 20% dropout, a sample size of 120 patients is needed to produce a two-sided 95% CI when the estimate of proportion (Grade 3 and higher neutropenia) is 55% (Occurrence rate of grade 3 and higher neutropenia is about 55% in Asia patients in NAPOLI-1).
Who may be able to join
- The adult patient (≥18 years of age) has given written informed consent to participate in the study.
- The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
- 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.
Who cannot join
- Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
- Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
- Pregnant or nursing (lactating) women.
- Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
- Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.
Primary objective
Read more
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
- Quantify the rate of grade ≥3 neutropenia (primary objective)
- Serious adverse events and serious adverse drug reactions
- Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. (1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
- Conditions
- Metastatic Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC | this is a prospective, single-arm, multicenter, open-label and non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(1) Quantify the rate of grade ≥3 neutropenia (primary objective)
Measured: From enrolment until 30 days after last ONIVYDE administration
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(2) Serious adverse events and serious adverse drug reactions
Measured: From enrolment until 30 days after last ONIVYDE administration
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
(3) Adverse events and adverse drug reactions
Measured: From enrolment until 30 days after last ONIVYDE administration
Secondary outcomes (4)
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(1) Overall survival
Measured: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(2) Overall response
Measured: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(3) Progression free survival
Measured: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
(4) Quality of life assessment(e.g.Karnofsky Performance Status (KPS))
Measured: From FPI to 12 months after LPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servier (Tianjin) Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688240
- Sponsor's protocol ID
- SAF-95013-001-CHN
- Acronym
- SEOPAC
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)
- ClinicalTrials.gov ID
- NCT06688240
- Acronym / sponsor ID
- SEOPAC / SAF-95013-001-CHN
- Conditions
- Metastatic Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Servier (Tianjin) Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Les Laboratoires Servier
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Nov 2024 (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 aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.
Primary objective
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
- Quantify the rate of grade ≥3 neutropenia (primary objective)
- Serious adverse events and serious adverse drug reactions
- Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland. (1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC | – | –this is a prospective, single-arm, multicenter, open-label and non-interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For a margin of error of 10% and to adjust for 20% dropout, a sample size of 120 patients is needed to produce a two-sided 95% CI when the estimate of proportion (Grade 3 and higher neutropenia) is 55% (Occurrence rate of grade 3 and higher neutropenia is about 55% in Asia patients in NAPOLI-1).
Key inclusion criteria (5 listed)
- The adult patient (≥18 years of age) has given written informed consent to participate in the study.
- The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.
- 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 (5 listed)
- Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.
- Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.
- Pregnant or nursing (lactating) women.
- Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.
- Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
Time frame: From enrolment until 30 days after last ONIVYDE administration
(1) Quantify the rate of grade ≥3 neutropenia (primary objective)
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
Time frame: From enrolment until 30 days after last ONIVYDE administration
(2) Serious adverse events and serious adverse drug reactions
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:
Time frame: From enrolment until 30 days after last ONIVYDE administration
(3) Adverse events and adverse drug reactions
4 secondary outcomes
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
Time frame: From FPI to 12 months after LPI
To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.
Time frame: From FPI to 12 months after LPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Pancreatic Cancer, run by Servier (Tianjin) Pharmaceutical Co. LTD..
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiaohui KANG Sr.PM (86+18500350333, qiaohui.kang@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects: (time frame: From enrolment until 30 days after last ONIVYDE administration). The study lists 3 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 14 Nov 2024.