Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-26 @ 9:31 PM
Study NCT ID:
NCT03177668
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status of onset of Dose Limiting Toxicity (DLT)', 'timeFrame': '18 days', 'description': 'Assessed by number of subjects with DLT of YS110'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '6 months', 'description': 'The proportion of subjects with assessed overall response as Complete Response (CR), Partial Response (PR) or Stable Disease (SD)'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Assessed for duration of study participation which is estimated to be 18 months', 'description': 'The period from the starting day of the administration to Progressive Disease (PD) or death'}, {'measure': 'Response Rate (RR)', 'timeFrame': 'Assessed for duration of study participation which is estimated to be 18 months', 'description': 'The proportion of subjects with assessed the best overall response as CR or PR'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Assessed for duration of study participation which is estimated to be 18 months', 'description': 'The period from the starting day of the administration to death'}, {'measure': 'LCSS-Meso', 'timeFrame': 'Assessed for duration of study participation which is estimated to be 18 months', 'description': 'Assessed for Quality of life (QOL) by using the modified Lung Cancer Symptom Scale for mesothelioma'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': 'Assessed for duration of study participation which is estimated to be 18 months', 'description': 'Assessed for QOL by using the Japanese versions of EORTC QLQ-C30 in the cancer patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with male or female aged ≥ 20 (and aged \\< 75 in Phase 1 part)\n* Patients whose malignant pleural mesothelioma was histologically confirmed\n* Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized\n* Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less\n\nExclusion Criteria:\n\n* Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored\n* Patients with tumor lesions in central nervous system confirmed in MRI or CT'}, 'identificationModule': {'nctId': 'NCT03177668', 'briefTitle': 'Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'YS1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YS110', 'description': 'Phase 1 part: Administration of 3 different dose cohort\n\nPhase 2 part: Administration of recommended dose determined from result of Phase 1 part', 'interventionNames': ['Drug: YS110']}], 'interventions': [{'name': 'YS110', 'type': 'DRUG', 'description': 'Intravenous administration', 'armGroupLabels': ['YS110']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Nobuo Kanai', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kissei Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}