Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-24 @ 2:34 PM
Study NCT ID:
NCT02106858
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2014-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stivarga Regulatory Post-Marketing Surveillance Study in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with serious adverse events', 'timeFrame': 'Up to 30 days after terminating treatment', 'description': 'Every 2 months (monthly safety assessment within first two cycles)'}, {'measure': 'Percentage of patients with adverse drug reactions (ADRs)', 'timeFrame': 'Up to 30 days after terminating treatment', 'description': 'Every 2 months (monthly safety assessment within first two cycles)'}], 'secondaryOutcomes': [{'measure': 'Overall response', 'timeFrame': 'Up to 6 years'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 6 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 6 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n* Signed and dated informed consent\n* Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician\n* Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time\n* Exclusion Criteria:\n* Patients participating in an investigational program with interventions outside of routine clinical practice\n* All contra-indications according to the local marketing authorization have to be considered.'}, 'identificationModule': {'nctId': 'NCT02106858', 'acronym': 'StivargaPMS', 'briefTitle': 'Stivarga Regulatory Post-Marketing Surveillance Study in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Stivarga® Regulatory Post-Marketing Surveillance Study in Korea', 'orgStudyIdInfo': {'id': '16778'}, 'secondaryIdInfos': [{'id': 'SV1314KR', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients treated by Physician with Stivarga under approved local prescriptions', 'interventionNames': ['Drug: Regorafenib (Stivarga,BAY73-4506)']}], 'interventions': [{'name': 'Regorafenib (Stivarga,BAY73-4506)', 'type': 'DRUG', 'description': 'Patients treated by Physician with Stivarga under approved local prescriptions', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'South Korea'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}