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)

NCT06688240 | Not Yet Recruiting

• 1 other identifier: SAF-95013-001-CHN
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Quantify the rate of grade ≥3 neutropenia (primary objective)
2. 2.Serious adverse events and serious adverse drug reactions
3. 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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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

  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.

  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.

  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.

  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.

  From FPI to 12 months after LPI

Study Arms (1)

prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC

this is a prospective, single-arm, multicenter, open-label and non-interventional study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier (Tianjin) Pharmaceutical Co. LTD.: lead
• Les Laboratoires Servier: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Qiaohui KANG Sr.PM

CONTACT

86+18500350333; qiaohui.kang@servier.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 14, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share