LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

LYNPARZA Tablets 100 mg, 150mg General Drug Use-results Study in Patients on Maintenance Treatment After Platinum-based Chemotherapy for BRCA Mutated Curatively Unresectable Pancreas Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04889404

Enrollment

130

Registered

2021-05-17

Start date

2021-05-22

Completion date

2025-02-06

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Brief 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.

Detailed 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events related to the safety specifications	from baseline to 1year	Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

Countries

Japan

Outcome results