Post Marketing Surveillance Study for ONIVYDE® in South Korea

Servier

Status: Completed

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: ONIVYDE; Drug: 5-fluorouracil; Drug: Leucovorin

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03446872

331602

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

94 participants in 1 patient group

All Study Participants

Description:

Patients in South Korea with a diagnosis of metastatic pancreatic cancer who have been prescribed ONIVYDE

Treatment:

Drug: Leucovorin

Drug: 5-fluorouracil

Drug: ONIVYDE