Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-02 @ 1:25 AM
Study NCT ID:
NCT05601232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate as assessed by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1', 'timeFrame': 'Baseline until Day90', 'description': 'Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT'}], 'secondaryOutcomes': [{'measure': 'Response rate as assessed by the investigator according to RECISTv1.1', 'timeFrame': 'Baseline until Day90', 'description': 'Percentage of patients with response (CR or PR) for target lesions within 90 days after BNCT'}, {'measure': 'Duration of response as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until disease progression or death', 'description': 'From the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first, until confirmed disease progression or death, whichever occurred first'}, {'measure': 'Time to response as assessed by the IRF', 'timeFrame': 'Baseline until the initial occurrence of CR or PR', 'description': 'From the date of BNCT until the initial occurrence of confirmed CR or PR for target lesions, whichever occurred at first'}, {'measure': 'Complete response (CR) rate as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until the initial occurrence of CR', 'description': 'Percentage of patients with CR for target lesions after BNCT'}, {'measure': 'Disease control rate as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until the initial occurrence of CR, PR or SD', 'description': 'Percentage of patients with CR, PR and SD for target lesions after BNCT'}, {'measure': 'Overall response rate as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until the initial occurrence of CR or PR', 'description': 'Percentage of patients with CR or PR after BNCT'}, {'measure': 'Locoregional progression-free survival as assessed by the investigator', 'timeFrame': 'Baseline until in-field disease progression', 'description': 'From the date of BNCT until confirmed in-field disease progression'}, {'measure': 'Extra-regional relapse-free survival as assessed by the investigator', 'timeFrame': 'Baseline until extra-field disease progression', 'description': 'From the date of BNCT until confirmed extra-field disease progression (new lesions)'}, {'measure': 'Progression-free survival as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until disease progression or death', 'description': 'From the date of BNCT until confirmed disease progression or death, whichever occurred first'}, {'measure': 'Maximum percent change in sum of tumor diameters of target lesions as assessed by the IRF and the investigator', 'timeFrame': 'Baseline until Day90', 'description': 'Maximum percent change in sum of tumor diameters of target lesions within 90 days after BNCT'}, {'measure': 'Overall survival', 'timeFrame': 'Baseline until death', 'description': 'From the date of BNCT until death from any causes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable Angiosarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained from the subject.\n* Histologically documented primary skin angiosarcoma.\n* Locally advanced or locally recurrent angiosarcoma, and not eligible for curative surgery, chemoradiotherapy or radiotherapy. (Including cases where the individual refuses treatment.)\n* Measurable disease, as defined by RECIST v1.1.\n* The longest diameter of the entire target lesion is 15 cm or less.\n* ECOG performance status score of Grade 0 to 2\n\nExclusion Criteria:\n\n* Apparent disseminated tumor lesions.\n* Hereditary fructose intolerance.\n* Phenylketonuria.\n* Any serious concomitant disease that precludes completion of the study treatment.\n* The target lesion has received radiation exceeding 75 Gy.'}, 'identificationModule': {'nctId': 'NCT05601232', 'briefTitle': 'A Phase II Study by Using CICS-1 and SPM-011 Commissioned by CICS and STELLA PHARMA', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stella Pharma Corporation'}, 'officialTitle': 'A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011', 'orgStudyIdInfo': {'id': 'CNCT-002/SPM-011-JAM002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boron Neutron Capture Therapy (BNCT)', 'interventionNames': ['Radiation: BNCT']}], 'interventions': [{'name': 'BNCT', 'type': 'RADIATION', 'description': 'Patients will be infused SPM-011 intravenously at a dose of 200mg/kg/hr over 2 hours. Thereafter, patient will be infused SPM-011 intravenously at a dose of 100mg/kg/hr and will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.', 'armGroupLabels': ['Boron Neutron Capture Therapy (BNCT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stella Pharma Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cancer Intelligence Care Systems, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}