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Completed

NCT Number: NCT04889404

LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

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.

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Osaka, Lyn010001, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of adverse events related to the safety specifications

    Time frame: from baseline to 1year

    Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 17, 2021
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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