NCT04889404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

60 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 22, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

May 12, 2021

Last Update Submit

January 13, 2026

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events related to the safety specifications

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

    from baseline to 1year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer

You may qualify if:

  • 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).

You may not qualify if:

  • Patients who have no treatment history with LYNPARZA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

Research Site

Osaka, Lyn010001, D081FC00004, Japan

Location

Research Site

Kanagawa, Lyn010003, D081FC00004, Japan

Location

Research Site

Okayama, Lyn010004, D081FC00004, Japan

Location

Research Site

Akita, Lyn010005, D081FC00004, Japan

Location

Research Site

Niigata, Lyn010006, D081FC00004, Japan

Location

Research Site

Shizuoka, Lyn010007, D081FC00004, Japan

Location

Research Site

Niigata, Lyn010008, D081FC00004, Japan

Location

Research Site

Tokyo, Lyn010009, D081FC00004, Japan

Location

Research Site

Saitama, Lyn010010, D081FC00004, Japan

Location

Research Site

Aichi, Lyn010011, D081FC00004, Japan

Location

Research Site

Osaka, Lyn010012, D081FC00004, Japan

Location

Research Site

Tokyo, Lyn010013, D081FC00004, Japan

Location

Research Site

Nara, Lyn010014, D081FC00004, Japan

Location

Research Site

Wakayama, Lyn010015, D081FC00004, Japan

Location

Research Site

Miyagi, Lyn010016, D081FC00004, Japan

Location

Research Site

Tokyo, Lyn010017, D081FC00004, Japan

Location

Research Site

Osaka, Lyn010018, D081FC00004, Japan

Location

Research Site

Gunma, Lyn010019, D081FC00004, Japan

Location

Research Site

Hiroshima, Lyn010020, Japan

Location

Research Site

Tochigi, Lyn010021, D081FC00004, Japan

Location

Research Site

Numakunai, Lyn010022, D081FC00004, Japan

Location

Research Site

Osaka, Lyn010025, D081FC00004, Japan

Location

Research Site

Shizuoka, Lyn010026, D081FC00004, Japan

Location

Research Site

Nagasaki, Lyn010027, D081FC00004, Japan

Location

Research Site

Kumamoto, Lyn010028, D081FC00004, Japan

Location

Research Site

Saitama, Lyn010029, D081FC00004, Japan

Location

Research Site

Nagano, Lyn010031, D081FC00004, Japan

Location

Research Site

Hyōgo, Lyn010032, D081FC00004, Japan

Location

Research Site

Shimane, Lyn010033, D081FC00004, Japan

Location

Research Site

Hyōgo, Lyn010034, D081FC00004, Japan

Location

Research Site

Shizuoka, Lyn010035, D081FC00004, Japan

Location

Research Site

Hyōgo, Lyn010036, D081FC00004, Japan

Location

Research Site

Okayama, Lyn010038, D081FC00004, Japan

Location

Research Site

Fukuoka, Lyn010041, Japan

Location

Research Site

Hokkaido, Lyn010042, Japan

Location

Research Site

Ehime, Lyn010044, Japan

Location

Research Site

Osaka, Lyn010045, Japan

Location

Research Site

Shizuoka, Lyn010047, Japan

Location

Research Site

Tokyo, Lyn010050, Japan

Location

Research Site

Aichi, Japan

Location

Research Site

Chiba, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Gunma, Japan

Location

Research Site

Hiroshima, Japan

Location

Research Site

Hokkaido, Japan

Location

Research Site

Hyōgo, Japan

Location

Research Site

Ibaraki, Japan

Location

Research Site

Kagawa, Japan

Location

Research Site

Kanagawa, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Nagano, Japan

Location

Research Site

Nagasaki, Japan

Location

Research Site

Nara, Japan

Location

Research Site

Okayama, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Shizuoka, Japan

Location

Research Site

Tokyo, Japan

Location

Research Site

Tottori, Japan

Location

Research Site

Toyama, Japan

Location

Research Site

Yamagata, Japan

Location

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Toshimitsu Tokimoto

    Astrazeneca KK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 17, 2021

Study Start

May 22, 2021

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

JP(60)