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) (SEOPAC)

November 13, 2024 updated by: Servier (Tianjin) Pharmaceutical Co. LTD.

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. Serious adverse events and serious adverse drug reactions
  3. 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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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:
Time Frame: From enrolment until 30 days after last ONIVYDE administration
(2) Serious adverse events and serious adverse drug reactions
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:
Time Frame: From enrolment until 30 days after last ONIVYDE administration
(3) Adverse events and adverse drug reactions
From enrolment until 30 days after last ONIVYDE administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
(1) Overall survival
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
(2) Overall response
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
(3) Progression free survival
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
(4) Quality of life assessment(e.g.Karnofsky Performance Status (KPS))
From FPI to 12 months after LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier (Tianjin) Pharmaceutical Co. LTD.

Collaborators

Les Laboratoires Servier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAF-95013-001-CHN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Pancreatic Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe