Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04889404
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2021-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events related to the safety specifications', 'timeFrame': 'from baseline to 1year', 'description': 'Safety specifications:Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity'}]}, 'conditionsModule': {'conditions': ['Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.\n\n\\*1: Bone marrow depression, interstitial lung disease, new primary malignancies, and embryofoetal toxicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients on maintenance treatment after platinum-based chemotherapy for BRCA mutated curatively unresectable pancreas cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* Patients who have no treatment history with LYNPARZA'}, 'identificationModule': {'nctId': 'NCT04889404', 'briefTitle': 'LYNPARZA Pancreas Cancer Japan Post-Marketing Surveillance (PMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D081FC00004'}}, 'contactsLocationsModule': {'locations': [{'zip': 'D081FC00004', 'city': 'Osaka', 'state': 'Lyn010001', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': 'D081FC00004', 'city': 'Kanagawa', 'state': 'Lyn010003', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': 'D081FC00004', 'city': 'Okayama', 'state': 'Lyn010004', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': 'D081FC00004', 'city': 'Akita', 'state': 'Lyn010005', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': 'D081FC00004', 'city': 'Niigata', 'state': 'Lyn010006', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': 'D081FC00004', 'city': 'Shizuoka', 'state': 'Lyn010007', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': 'D081FC00004', 'city': 'Niigata', 'state': 'Lyn010008', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': 'D081FC00004', 'city': 'Tokyo', 'state': 'Lyn010009', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'D081FC00004', 'city': 'Saitama', 'state': 'Lyn010010', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': 'D081FC00004', 'city': 'Aichi', 'state': 'Lyn010011', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': 'D081FC00004', 'city': 'Osaka', 'state': 'Lyn010012', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': 'D081FC00004', 'city': 'Tokyo', 'state': 'Lyn010013', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'D081FC00004', 'city': 'Nara', 'state': 'Lyn010014', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': 'D081FC00004', 'city': 'Wakayama', 'state': 'Lyn010015', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': 'D081FC00004', 'city': 'Miyagi', 'state': 'Lyn010016', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'zip': 'D081FC00004', 'city': 'Tokyo', 'state': 'Lyn010017', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': 'D081FC00004', 'city': 'Osaka', 'state': 'Lyn010018', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': 'D081FC00004', 'city': 'Gunma', 'state': 'Lyn010019', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hiroshima', 'state': 'Lyn010020', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': 'D081FC00004', 'city': 'Tochigi', 'state': 'Lyn010021', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': 'D081FC00004', 'city': 'Numakunai', 'state': 'Lyn010022', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'zip': 'D081FC00004', 'city': 'Osaka', 'state': 'Lyn010025', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': 'D081FC00004', 'city': 'Shizuoka', 'state': 'Lyn010026', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': 'D081FC00004', 'city': 'Nagasaki', 'state': 'Lyn010027', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': 'D081FC00004', 'city': 'Kumamoto', 'state': 'Lyn010028', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': 'D081FC00004', 'city': 'Saitama', 'state': 'Lyn010029', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': 'D081FC00004', 'city': 'Nagano', 'state': 'Lyn010031', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': 'D081FC00004', 'city': 'Hyōgo', 'state': 'Lyn010032', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': 'D081FC00004', 'city': 'Shimane', 'state': 'Lyn010033', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'zip': 'D081FC00004', 'city': 'Hyōgo', 'state': 'Lyn010034', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': 'D081FC00004', 'city': 'Shizuoka', 'state': 'Lyn010035', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': 'D081FC00004', 'city': 'Hyōgo', 'state': 'Lyn010036', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': 'D081FC00004', 'city': 'Okayama', 'state': 'Lyn010038', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Fukuoka', 'state': 'Lyn010041', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hokkaido', 'state': 'Lyn010042', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Ehime', 'state': 'Lyn010044', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Osaka', 'state': 'Lyn010045', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Shizuoka', 'state': 'Lyn010047', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'state': 'Lyn010050', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tottori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Yamagata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Toshimitsu Tokimoto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca KK'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}