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
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.
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.
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).
Cohort
Prospective
Not listed
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)
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
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
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
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
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
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))
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Servier (Tianjin) Pharmaceutical Co. LTD.
Lead sponsor
Les Laboratoires Servier
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
