Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03030066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with dose limiting toxicities', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants experiencing an adverse event (AE)', 'timeFrame': 'up to 36 months', 'description': 'AEs temporally associated with DS-1001b treatment'}, {'measure': 'Area under the concentration curve (AUC) for DS-1001b', 'timeFrame': 'up to 36 months'}, {'measure': 'Maximum plasma concentration (Cmax) for DS-1001b', 'timeFrame': 'up to 36 months'}, {'measure': 'Time to maximum plasma concentration (Tmax) for DS-1001b', 'timeFrame': 'up to 36 months'}, {'measure': 'Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b', 'timeFrame': 'Baseline, up to 36 months'}, {'measure': 'Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)', 'timeFrame': 'up to 36 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DS-1001b', 'IDH1 mutation', 'Developmental Phase I', 'Glioma'], 'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has histologically confirmed glioma with an IDH1-R132 mutation\n2. Has disease that has recurred or progressed following standard treatment including radiotherapy\n3. Has measurable lesion(s) as per RANO criteria\n4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\nExclusion Criteria:\n\n1. Has significant symptoms of increased intracranial pressure\n2. Has another active neoplasm\n3. Has active infection requiring systemic treatment\n4. Has a history of severe cardiac disease\n5. Has had prior treatment with any inhibitor targeting mutant IDH1\n6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment\n7. Is a pregnant or lactating female'}, 'identificationModule': {'nctId': 'NCT03030066', 'briefTitle': 'Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas', 'orgStudyIdInfo': {'id': 'DS1001-A-J101'}, 'secondaryIdInfos': [{'id': '163479', 'type': 'REGISTRY', 'domain': 'JAPIC CTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Drug DS-1001b', 'description': 'Oral administration', 'interventionNames': ['Drug: DS-1001b']}], 'interventions': [{'name': 'DS-1001b', 'type': 'DRUG', 'otherNames': ['Investigational'], 'description': 'Generic not assigned', 'armGroupLabels': ['Experimental Drug DS-1001b']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}