Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-20 @ 6:32 PM
Study NCT ID:
NCT01563302
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2012-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'dispFirstSubmitDate': '2018-06-20', 'completionDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2012-02-13', 'dispFirstSubmitQcDate': '2018-06-20', 'studyFirstSubmitQcDate': '2012-03-22', 'dispFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of IONIS-STAT3Rx in patients with Advanced Cancers', 'timeFrame': 'Approximately 28 days after last dose of IONIS -STAT3Rx'}, {'measure': 'Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.', 'timeFrame': 'Approximately 28 Days', 'description': 'Highest dose level at which no more than 1 out of 6 patients develops a DLT'}], 'secondaryOutcomes': [{'measure': 'Clinical activity of IONIS-STAT3Rx', 'timeFrame': 'Approximately 28 Days after last dose of IONIS-STAT3Rx', 'description': 'Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria'}, {'measure': 'Pharmacokinetics-Cmax', 'timeFrame': 'Approximately 28 days after last dose of IONIS-STAT3Rx', 'description': 'Maximum observed drug concentration (Cmax)'}, {'measure': 'STAT3 and other biomarkers', 'timeFrame': 'Approximately 28 days after last dose of IONIS-STAT3Rx', 'description': 'The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers'}, {'measure': 'Pharmacokinetics - Tmax', 'timeFrame': 'Approximately 28 days after last dose of IONIS-STAT3Rx', 'description': 'Time taken to reach Cmax'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Cancers', 'DLBCL', 'Advanced Lymphoma'], 'conditions': ['Advanced Cancers', 'DLBCL', 'Lymphoma']}, 'referencesModule': {'references': [{'pmid': '30446007', 'type': 'DERIVED', 'citation': 'Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists\n* Expansion cohort only: Advanced lymphoma confirmed by histopathology\n* Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors\n* ECOG Performance Status less than or equal to 2\n* Life expectancy greater than 12 weeks in the opinion of the Investigator\n\nExclusion Criteria:\n\n* Any active or uncontrolled infection\n* NYHA Grade II or greater congestive heart failure\n* History of myocardial infarction within 6 months prior to screening\n* Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter'}, 'identificationModule': {'nctId': 'NCT01563302', 'briefTitle': 'Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers', 'orgStudyIdInfo': {'id': 'ISIS 481464-CS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'IONIS-STAT3Rx', 'interventionNames': ['Drug: IONIS-STAT3Rx']}], 'interventions': [{'name': 'IONIS-STAT3Rx', 'type': 'DRUG', 'otherNames': ['ISIS 481464'], 'description': 'Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UC San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Blood and Marrow Transplant Group of Georgia at Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Mary Crowley Cancer Research Centers', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Steve Hughes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ionis Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}