Trials / Completed
CompletedNCT04889404
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Conditions
Timeline
- Start date
- 2021-05-22
- Primary completion
- 2025-02-06
- Completion
- 2025-02-06
- First posted
- 2021-05-17
- Last updated
- 2026-01-14
Locations
60 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT04889404. Inclusion in this directory is not an endorsement.