Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-06 @ 2:25 AM
Study NCT ID:
NCT02612558
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2015-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-02', 'releaseDate': '2024-03-05'}], 'estimatedResultsFirstSubmitDate': '2024-03-05'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C523665', 'term': 'fostamatinib'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin response', 'timeFrame': 'by Week 24', 'description': 'Hemoglobin level of \\> 10 g/dL and 2 g/dL higher than the baseline hemoglobin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Warm antibody autoimmune hemolytic anemia (AIHA)'], 'conditions': ['Warm Antibody Autoimmune Hemolytic Anemia']}, 'referencesModule': {'references': [{'pmid': '35179251', 'type': 'DERIVED', 'citation': 'Kuter DJ, Rogers KA, Boxer MA, Choi M, Agajanian R, Arnold DM, Broome CM, Field JJ, Murakhovskaya I, Numerof R, Tong S. Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study. Am J Hematol. 2022 Jun 1;97(6):691-699. doi: 10.1002/ajh.26508. Epub 2022 Mar 3.'}], 'seeAlsoLinks': [{'url': 'http://www.aihastudy.com', 'label': 'www.aihastudy.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject must have had a diagnosis of primary or secondary warm antibody AIHA.\n\n\\- Must have failed at least 1 prior treatment regimen for AIHA.\n\nExclusion Criteria:\n\n* Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.\n* Subject with a platelet count of \\< 30,000/μL.\n* Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.\n* Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.'}, 'identificationModule': {'nctId': 'NCT02612558', 'acronym': 'SOAR', 'briefTitle': 'A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rigel Pharmaceuticals'}, 'officialTitle': 'A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia', 'orgStudyIdInfo': {'id': 'C-935788-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fostamatinib 150 mg', 'description': 'Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks', 'interventionNames': ['Drug: Fostamatinib 150 mg bid']}], 'interventions': [{'name': 'Fostamatinib 150 mg bid', 'type': 'DRUG', 'otherNames': ['R935788', 'R788', 'Fostamatinib', 'Tavalisse'], 'description': 'Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.', 'armGroupLabels': ['Fostamatinib 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Cancer Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC/USC Health Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Institute of Hope and Innovation', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid-Florida Hematology & Oncology Centers, P.A.', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '40353', 'city': 'Mount Sterling', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Montgomery Cancer Center', 'geoPoint': {'lat': 38.05647, 'lon': -83.94326}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School Of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Rcca Md Llc', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48640', 'city': 'Midland', 'state': 'Michigan', 'country': 'United States', 'facility': 'MidMichigan Health Cancer Center', 'geoPoint': {'lat': 43.61558, 'lon': -84.24721}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Brody School of Medicine at East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'W.G. 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Francisco Gonzalez, M.D., P.A.', 'geoPoint': {'lat': 33.92044, 'lon': -80.34147}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology San Antonio Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Clear Lake Specialties', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences- McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T IE2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Rigel Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigel Pharmaceuticals,Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-05', 'type': 'RELEASE'}, {'date': '2024-04-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rigel Pharmaceuticals'}}}}