Post Marketing Surveillance Study for ONIVYDE® in South Korea

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Servier

Status

Completed

Conditions

Metastatic Pancreatic Cancer

Treatments

Drug: 5-fluorouracil
Drug: ONIVYDE
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: ONIVYDE
Drug: 5-fluorouracil

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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