[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381346":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":56,"centralContacts":61,"locations":68,"responsibleParty":192,"collaborators":194,"id":210,"slug":211,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":49,"eligibilityCriteria":216,"healthyVolunteers":212,"sex":217,"minAge":218,"maxAge":49,"enrollmentInfo":219,"targetDuration":49,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":71,"whyStopped":49,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"fullName":5,"class":6},"Syntrix Biosystems, Inc.","INDUSTRY",[8,14,18,22,27,31,35,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation of SX-682","EXPERIMENTAL","Escalating oral doses of SX-682 (study drug) of 25, 50, 100, 200 and 400 mg twice-daily (i.e., 50, 100, 200, 400 and 800 mg total each day.",[13],"Drug: SX-682",{"label":15,"type":10,"description":16,"interventionNames":17},"Expansion of SX-682 alone (lower risk patients, naive to hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who have never received hypomethylating agents.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Expansion of SX-682 alone (lower risk patients, failed on hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in lower risk patients who failed on hypomethylating agents.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Expansion of SX-682 with decitabine (lower risk patients, naive to hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who have never received hypomethylating agents.",[13,26],"Drug: Decitabine",{"label":28,"type":10,"description":29,"interventionNames":30},"Expansion of SX-682 with decitabine (lower risk patients, failed on hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in lower risk patients who failed on hypomethylating agents.",[13,26],{"label":32,"type":10,"description":33,"interventionNames":34},"Expansion of SX-682 alone (higher risk patients, failed on hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 200 mg twice daily (recommended phase 2 dose) in higher risk patients who failed on hypomethylating agents.",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Expansion of SX-682 with decitabine (higher risk patients, naive to hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who have never received hypomethylating agents.",[13,26],{"label":40,"type":10,"description":41,"interventionNames":42},"Expansion of SX-682 with decitabine (higher risk patients, failed on hypomethylating agents)","Expansion of oral doses of SX-682 (study drug) at 100 mg twice daily with decitabine in higher risk patients who failed on hypomethylating agents.",[13,26],[44,50],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","SX-682","SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)",[9,32,19,15,40,36,28,23],null,{"type":45,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Decitabine","Decitabine is a hypomethylating agent.",[40,36,28,23],[55],"DEC-C",[57],{"name":58,"affiliation":59,"role":60},"David A Sallman, MD","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":66,"email":67},"Aaron D Schuler, PhD","CONTACT","253-833-8009","21","aschuler@syntrixbio.com",[69,90,105,121,139,156,173],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Mayo Clinic","RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-81.65565,30.33218,{"lat":81,"lon":80},[84,88],{"name":85,"role":64,"phone":86,"phoneExt":49,"email":87},"David Hodges, EMT","904-953-5200","Hodges.David@mayo.edu",{"name":89,"role":60,"phone":49,"phoneExt":49,"email":49},"Hemant S Murthy, MD",{"facility":91,"status":71,"city":92,"state":73,"zip":93,"country":75,"countryCode":76,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Miami","Miami","33136",{"type":78,"coordinates":95},[96,97],-80.19366,25.77427,{"lat":97,"lon":96},[100,104],{"name":101,"role":64,"phone":102,"phoneExt":49,"email":103},"Namrata S Chandhok, MD","305-243-8238","namrata.chandhok@miami.edu",{"name":101,"role":60,"phone":49,"phoneExt":49,"email":49},{"facility":106,"status":71,"city":107,"state":73,"zip":108,"country":75,"countryCode":76,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"AdventHealth Medical Group & Bone Marrow Transplant at Orlando","Orlando","32804",{"type":78,"coordinates":110},[111,112],-81.37924,28.53834,{"lat":112,"lon":111},[115,119],{"name":116,"role":64,"phone":117,"phoneExt":49,"email":118},"Kristen Wing, RN,BSN,CCRP","407-303-8251","Kristen.Wing@adventhealth.com",{"name":120,"role":60,"phone":49,"phoneExt":49,"email":49},"Arlene Gayle, M.D.",{"facility":59,"status":71,"city":122,"state":73,"zip":123,"country":75,"countryCode":76,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Tampa","33612",{"type":78,"coordinates":125},[126,127],-82.45843,27.94752,{"lat":127,"lon":126},[130,134,138],{"name":131,"role":64,"phone":132,"phoneExt":49,"email":133},"Charlie Riesebeck","813-745-3884","Charlie.Riesebeck@moffitt.org",{"name":135,"role":64,"phone":136,"phoneExt":49,"email":137},"Cyril Patra, MPH","813-745-2802","Cyril.Patra@moffitt.org",{"name":58,"role":60,"phone":49,"phoneExt":49,"email":49},{"facility":140,"status":71,"city":141,"state":142,"zip":143,"country":75,"countryCode":76,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Emory University","Atlanta","Georgia","30322",{"type":78,"coordinates":145},[146,147],-84.38798,33.749,{"lat":147,"lon":146},[150,154],{"name":151,"role":64,"phone":152,"phoneExt":49,"email":153},"Danielle Alexander, MS","404-778-3663","danielle.oliver@emory.edu",{"name":155,"role":60,"phone":49,"phoneExt":49,"email":49},"Anthony M Hunter, MD",{"facility":157,"status":71,"city":158,"state":159,"zip":160,"country":75,"countryCode":76,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","Baltimore","Maryland","21287",{"type":78,"coordinates":162},[163,164],-76.61219,39.29038,{"lat":164,"lon":163},[167,171],{"name":168,"role":64,"phone":169,"phoneExt":49,"email":170},"Lisa A. Kelemen, RN, MSN","410-614-4618","lkeleme1@jhmi.edu",{"name":172,"role":60,"phone":49,"phoneExt":49,"email":49},"Amy E DeZern, MD, MHS",{"facility":174,"status":71,"city":175,"state":176,"zip":177,"country":75,"countryCode":76,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Montefiore Medical Center","The Bronx","New York","10467",{"type":78,"coordinates":179},[180,181],-73.86641,40.84985,{"lat":181,"lon":180},[184,187,191],{"name":185,"role":64,"phone":49,"phoneExt":49,"email":186},"Mendel Goldfinger, MD","clinicaltrials@syntrixbio.com",{"name":188,"role":64,"phone":189,"phoneExt":49,"email":190},"Anne Munoz, RN","718-920-2006","anmunoz@montefiore.org",{"name":185,"role":60,"phone":49,"phoneExt":49,"email":49},{"type":193,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[195,198,201,203,204,205,206,207,209],{"name":196,"class":197},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",{"name":199,"class":200},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":202,"class":197},"AdventHealth",{"name":140,"class":197},{"name":91,"class":197},{"name":70,"class":197},{"name":174,"class":197},{"name":208,"class":200},"National Cancer Institute (NCI)",{"name":157,"class":197},"100381346","phase-1-study-of-sx-682-alone-and-in-combination-with-oral-or-intravenous-decitabine-in-subjects-with-myelodysplastic-syndrome-100381346",false,"NCT04245397","Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome","A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Diagnosis of MDS by World Health Organization criteria, and either\n\n  1. International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk patients without 5q deletion:\n\n     i. Dose escalation portion: failed prior treatment with at least 4 cycles started of a hypomethylating agent (HMA; azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease\u002Fintolerance to therapy.\n\n     ii. Dose expansion portion: failed prior treatment defined as no response to treatment with at least 4 cycles started of HMA, loss of response at any time point, or progressive disease\u002Fintolerance to therapy (\"HMA failure\"); or no prior treatment with HMA (\"HMA naive\").\n  2. IPSS low risk or intermediate-1 risk patients with 5q deletion:\n\n     i. Dose escalation portion: failed prior treatment with at least 4 cycles started of lenalidomide and 4 cycles of hypomethylating agent (azacitidine or decitabine) defined as no response to treatment, loss of response at any time point, or progressive disease\u002Fintolerance to therapy.\n\n     ii. Dose expansion portion: same as non-del(5q) lower risk cohort + requirement of failed prior treatment with lenalidomide defined as no response to treatment with at least 4 cycles started of lenalidomide, loss of response at any time point, or progressive disease\u002Fintolerance to therapy.\n  3. IPSS intermediate-2 risk or high risk patients: HMA failure or HMA naïve as defined above.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* Screening laboratory values:\n\n  1. Renal glomerular filtration rate (GFR) ≥ 30 ml\u002Fmin;\n  2. Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) ≤ 3.0 times upper limit of normal;\n  3. Bilirubin \\\u003C 1.5 times upper limit of normal;\n  4. No history of HIV being HIV positive;\n  5. No active Hepatitis B or Hepatitis C infection.\n* Life expectancy ≥ 12 weeks.\n* Women of childbearing potential (WOCBP) must use study specified contraception.\n* WOCBP demonstrate negative pregnancy test.\n* Not breastfeeding.\n* Men sexually active must use study specified contraception.\n\nExclusion Criteria:\n\n* Use of chemotherapeutic agents or experimental agents for MDS within 14 days of the first day of study drug treatment.\n* Use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF), or Granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of the first day of study drug treatment, or during the study.\n* Mean triplicate heart rate-corrected QT interval (QTc) \\> 500 msec.\n* Any of the following cardiac abnormalities:\n\n  1. QT interval \\> 480 msec corrected using Fridericia's formula;\n  2. Risk factors for Torsade de Pointes;\n  3. Use of medication that prolongs the QT interval with the exception of drugs that are considered absolutely essential for the care of the subject;\n  4. Myocardial infarction ≤ 6 months prior to first day of study drug treatment;\n  5. Unstable angina pectoris or serious uncontrolled cardiac arrhythmia.\n* Any serious or uncontrolled medical disorder.\n* Prior malignancy within the previous 2 years except for local cancers that have been cured; or patients who have been adequately treated and have low risk of reoccurrence.\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Use of other investigational drugs within 30 days of study drug administration.\n* Major surgery within 4 weeks of study drug administration.\n* Live-virus vaccination within 30 days of study drug administration.\n* Allergy to study drug component.","ALL","18 Years",{"count":220,"type":221},151,"ESTIMATED","INTERVENTIONAL",[224],"PHASE1","This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).",[227],"Myelodysplastic Syndromes",[229,230,231],"Immunotherapy","Chemokine receptor blockade","Myeloid-derived supressor cells","2025-12-19",{"date":234,"type":235},"2025-12-23","ACTUAL",{"date":237,"type":235},"2020-06-30",{"date":239,"type":221},"2029-03",{"name":5,"class":6},7]