Pancreatic NeoplasmsNCT04889404
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
An observational study of Pancreatic Neoplasms, run by AstraZeneca at 60 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Neoplasms
- How many people
- 130 participants
- Where
- 60 sitesJapan
- Study dates
- 22 May 2021to 6 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer
Who may be able to join
- 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).
Who cannot join
- Patients who have no treatment history with LYNPARZA
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
Japan60 sites
Research Site
Aichi, Lyn010011, D081FC00004
Research Site
Aichi
Research Site
Akita, Lyn010005, D081FC00004
Research Site
Chiba
Research Site
Ehime, Lyn010044
Research Site
Fukuoka, Lyn010041
Research Site
Fukuoka
Research Site
Gunma, Lyn010019, D081FC00004
Research Site
Gunma
Research Site
Hiroshima, Lyn010020
Research Site
Hiroshima
Research Site
Hokkaido, Lyn010042
Research Site
Hokkaido
Research Site
Hyōgo, Lyn010032, D081FC00004
Research Site
Hyōgo, Lyn010034, D081FC00004
Research Site
Hyōgo, Lyn010036, D081FC00004
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Kagawa
Research Site
Kanagawa, Lyn010003, D081FC00004
Research Site
Kanagawa
Research Site
Kumamoto, Lyn010028, D081FC00004
Research Site
Kyoto
Research Site
Miyagi, Lyn010016, D081FC00004
Research Site
Nagano, Lyn010031, D081FC00004
Research Site
Nagano
Research Site
Nagasaki, Lyn010027, D081FC00004
Research Site
Nagasaki
Research Site
Nara, Lyn010014, D081FC00004
Research Site
Nara
Research Site
Niigata, Lyn010006, D081FC00004
Research Site
Niigata, Lyn010008, D081FC00004
Research Site
Numakunai, Lyn010022, D081FC00004
Research Site
Okayama, Lyn010004, D081FC00004
Research Site
Okayama, Lyn010038, D081FC00004
Research Site
Okayama
Research Site
Osaka, Lyn010001, D081FC00004
Research Site
Osaka, Lyn010012, D081FC00004
Research Site
Osaka, Lyn010018, D081FC00004
Research Site
Osaka, Lyn010025, D081FC00004
Research Site
Osaka, Lyn010045
Research Site
Osaka
Research Site
Saitama, Lyn010010, D081FC00004
Research Site
Saitama, Lyn010029, D081FC00004
Research Site
Shimane, Lyn010033, D081FC00004
Research Site
Shizuoka, Lyn010007, D081FC00004
Research Site
Shizuoka, Lyn010026, D081FC00004
Research Site
Shizuoka, Lyn010035, D081FC00004
Research Site
Shizuoka, Lyn010047
Research Site
Shizuoka
Research Site
Tochigi, Lyn010021, D081FC00004
Research Site
Tokyo, Lyn010009, D081FC00004
Research Site
Tokyo, Lyn010013, D081FC00004
Research Site
Tokyo, Lyn010017, D081FC00004
Research Site
Tokyo, Lyn010050
Research Site
Tokyo
Research Site
Tottori
Research Site
Toyama
Research Site
Wakayama, Lyn010015, D081FC00004
Research Site
Yamagata
About this study
Official 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
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.
Read the 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
- Pancreatic Neoplasms
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events related to the safety specifications
Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity
Measured: from baseline to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start22 May 2021
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshimitsu Tokimoto, Study director, Astrazeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889404
- Sponsor's protocol ID
- D081FC00004
- Status last verified
- Jan 2026
- First submitted
- 12 May 2021
- Last updated
- 14 Jan 2026
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04889404
- Acronym / sponsor ID
- D081FC00004
- Conditions
- Pancreatic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 May 2021 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients who have no treatment history with LYNPARZA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshimitsu Tokimoto study director
Astrazeneca KK
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by AstraZeneca at 60 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events related to the safety specifications (time frame: from baseline to 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.