LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    110
  • sponsor
    AstraZeneca
Updated on 16 September 2021
cancer chemotherapy

Summary

To collect and characterise the incidence of adverse events related to the safety specifications of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.

Description

To collect and characterise the incidence of adverse events related to the safety specifications*1 of the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated pancreatic cancer under the actual post-marketing use of LYNPAZA.

This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

Details
Condition Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, pancreatic neoplasm
Clinical Study IdentifierNCT04889404
SponsorAstraZeneca
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who receive LYNPARZA for the first time for the maintenance treatment after platinum-based chemotherapy in patients with BRCA mutated curatively unresectable pancreas cancer after the approval date of partial change application for the additional indication (25/Dec./2020)

Exclusion Criteria

Patients who have no treatment history with LYNPARZA
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