LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

AstraZeneca

Status: Completed

Conditions: Pancreatic Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT04889404

D081FC00004

Details and patient eligibility

About

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.

Full 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

Enrollment: 130 patients

Sex: All

Volunteers: No Healthy Volunteers

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