Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-12 @ 11:16 PM
Study NCT ID:
NCT02192567
Status:
TERMINATED
Last Update Posted:
2017-03-03
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study of DS-5573a
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613983', 'term': 'DS-5573a'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects experiencing dose limiting toxicities', 'timeFrame': 'Day 1 through Day 28', 'description': 'Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.'}, {'measure': 'Number of subjects experiencing adverse events', 'timeFrame': 'Day 1 through 45 days after last dose', 'description': 'Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.'}, {'measure': 'Pharmacokinetic profile of DS-5573a', 'timeFrame': 'Cycle 1 - Day 1 through Cycle 8 - Day 1', 'description': 'Pharmacokinetic profile of DS-5573a. \\[Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1\\] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.'}], 'secondaryOutcomes': [{'measure': 'Incidence of human anti-human antibodies (HAHA) against DS-5573a', 'timeFrame': 'Cycle 1 - Day 1 through Cycle 1 - Day 15.', 'description': 'Incidence of human anti-human antibodies (HAHA) against DS-5573a.'}, {'measure': 'Assessment of tumor response to DS-5573a using RECIST ver1.1.', 'timeFrame': 'week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90', 'description': 'Assessment of tumor response is conducted every 6 weeks during the study until study end or the subject discontinues participation.'}, {'measure': 'Assessment of DS-5573a-related biomarkers in blood and tumor', 'timeFrame': 'Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2', 'description': 'Assessment of DS-5573a-related biomarkers in blood and tumor.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced solid malignant tumor', 'phase 1', 'oncology'], 'conditions': ['Advanced Solid Malignant Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.\n* Eastern Cooperative Oncology Group performance status(PS) of 0 or 1\n\nExclusion Criteria:\n\n* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:\n\nCardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.\n\n* Severe or uncontrolled concomitant disease.\n* Clinically active brain metastases defined as symptomatic or requiring treatment.'}, 'identificationModule': {'nctId': 'NCT02192567', 'briefTitle': 'Open Label Study of DS-5573a', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors', 'orgStudyIdInfo': {'id': 'DS5573-A-J101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DS-5573a does escalation (step 1) and expansion (step 2)', 'description': 'Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg.\n\nEight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.', 'interventionNames': ['Drug: DS-5573a']}], 'interventions': [{'name': 'DS-5573a', 'type': 'DRUG', 'description': 'Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg.\n\nStep 2: 30 subjects will use the dose determined in Step 1.', 'armGroupLabels': ['DS-5573a does escalation (step 1) and expansion (step 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104-0045', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kenji Tamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}