LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)

NCT ID: NCT04889404

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-22

Study Completion Date

2025-02-06

Brief Summary

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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

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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

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Pancreatic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

Astrazeneca KK

Locations

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Research Site

Osaka, Lyn010001, Japan

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Kanagawa, Lyn010003, Japan

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Okayama, Lyn010004, Japan

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Akita, Lyn010005, Japan

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Niigata, Lyn010006, Japan

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Shizuoka, Lyn010007, Japan

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Niigata, Lyn010008, Japan

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Tokyo, Lyn010009, Japan

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Saitama, Lyn010010, Japan

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Aichi, Lyn010011, Japan

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Osaka, Lyn010012, Japan

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Tokyo, Lyn010013, Japan

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Nara, Lyn010014, Japan

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Wakayama, Lyn010015, Japan

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Miyagi, Lyn010016, Japan

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Tokyo, Lyn010017, Japan

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Osaka, Lyn010018, Japan

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Gunma, Lyn010019, Japan

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Hiroshima, Lyn010020, Japan

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Tochigi, Lyn010021, Japan

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Numakunai, Lyn010022, Japan

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Osaka, Lyn010025, Japan

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Shizuoka, Lyn010026, Japan

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Nagasaki, Lyn010027, Japan

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Kumamoto, Lyn010028, Japan

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Saitama, Lyn010029, Japan

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Nagano, Lyn010031, Japan

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Hyōgo, Lyn010032, Japan

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Shimane, Lyn010033, Japan

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Hyōgo, Lyn010034, Japan

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Shizuoka, Lyn010035, Japan

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Hyōgo, Lyn010036, Japan

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Okayama, Lyn010038, Japan

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Fukuoka, Lyn010041, Japan

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Hokkaido, Lyn010042, Japan

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Ehime, Lyn010044, Japan

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Osaka, Lyn010045, Japan

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Shizuoka, Lyn010047, Japan

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Tokyo, Lyn010050, Japan

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Aichi, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Kagawa, , Japan

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Kanagawa, , Japan

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Kyoto, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Nara, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tottori, , Japan

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Toyama, , Japan

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Yamagata, , Japan

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Countries

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Japan

Other Identifiers

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D081FC00004

Identifier Type: -

Identifier Source: org_study_id

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