[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100331224":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":48,"locations":56,"responsibleParty":423,"collaborators":40,"id":425,"slug":426,"hasResults":427,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":40,"eligibilityCriteria":431,"healthyVolunteers":427,"sex":432,"minAge":433,"maxAge":40,"enrollmentInfo":434,"targetDuration":40,"studyType":437,"phases":438,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":197,"whyStopped":40,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},{"fullName":5,"class":6},"Xynomic Pharmaceuticals, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pazopanib plus abexinostat","EXPERIMENTAL","Randomized patients will receive a combination of pazopanib plus abexinostat. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat p.o twice daily (BID) on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of abexinostat at the same time each day.",[13,14],"Drug: Pazopanib","Drug: Abexinostat",{"label":16,"type":17,"description":18,"interventionNames":19},"Pazopanib plus placebo","PLACEBO_COMPARATOR","Randomized patients will receive a combination of pazopanib plus abexinostat matching placebo. The patients will receive pazopanib by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle and will receive abexinostat matching placebo p.o BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Patients will be instructed to take their once- daily oral dose of pazopanib and BID oral dose of placebo at the same time each day.",[13,20],"Other: Placebo",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Pazopanib","All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz\u002F240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.",[9,16],[28],"Votrient®",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Abexinostat","The starting dose and schedule of abexinostat will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of abexinostat should be taken with an 8 oz\u002F240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.",[9],[34],"PCI-24781",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"OTHER","Placebo","The starting dose and schedule of abexinostat matching placebo will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of placebo should be taken with an 8 oz\u002F240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.",[16],null,[42,46],{"name":43,"affiliation":44,"role":45},"Pamela Munster, M.D.","University of California, San Francisco","STUDY_CHAIR",{"name":47,"affiliation":44,"role":45},"Rahul Aggarwal, M.D.",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":40,"email":53},"Sophia Paspal, Ph.D.","CONTACT","6104055974","sophia.paspal@xynomicpharma.com",{"name":47,"role":51,"phone":40,"phoneExt":40,"email":55},"rahul.aggarwal@ucsf.edu",[57,71,81,90,101,111,121,126,136,145,155,165,175,185,195,212,227,238,247,256,265,274,283,292,301,310,321,330,339,348,358,367,376,382,388,399,408,414],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":40},"University Of UA Cancer Center(UACC)\u002FDH-SJHMC","WITHDRAWN","Phoenix","Arizona","85004","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-112.07404,33.44838,{"lat":69,"lon":68},{"facility":72,"status":59,"city":73,"state":74,"zip":75,"country":63,"countryCode":64,"cosmosGeoPoint":76,"geoPoint":80,"contacts":40},"University of California Davis Comprehensive Cancer Center","Sacramento","California","95817",{"type":66,"coordinates":77},[78,79],-121.4944,38.58157,{"lat":79,"lon":78},{"facility":82,"status":59,"city":83,"state":74,"zip":84,"country":63,"countryCode":64,"cosmosGeoPoint":85,"geoPoint":89,"contacts":40},"UCSF Helen Diller Family Comphrensive Cancer Center - Hemato","San Francisco","94158",{"type":66,"coordinates":86},[87,88],-122.41942,37.77493,{"lat":88,"lon":87},{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":63,"countryCode":64,"cosmosGeoPoint":96,"geoPoint":100,"contacts":40},"Norton Cancer Institute, Norton Healthcare Pavilion","COMPLETED","Louisville","Kentucky","40202",{"type":66,"coordinates":97},[98,99],-85.75941,38.25424,{"lat":99,"lon":98},{"facility":102,"status":92,"city":103,"state":104,"zip":105,"country":63,"countryCode":64,"cosmosGeoPoint":106,"geoPoint":110,"contacts":40},"Ochsner Clinic Foundation","New Orleans","Louisiana","70121",{"type":66,"coordinates":107},[108,109],-90.07507,29.95465,{"lat":109,"lon":108},{"facility":112,"status":59,"city":113,"state":114,"zip":115,"country":63,"countryCode":64,"cosmosGeoPoint":116,"geoPoint":120,"contacts":40},"GU Research Network\u002FUrology Cancer Center","Omaha","Nebraska","68130",{"type":66,"coordinates":117},[118,119],-95.94043,41.25626,{"lat":119,"lon":118},{"facility":122,"status":92,"city":113,"state":114,"zip":115,"country":63,"countryCode":64,"cosmosGeoPoint":123,"geoPoint":125,"contacts":40},"Nebraska Cancer Specialists",{"type":66,"coordinates":124},[118,119],{"lat":119,"lon":118},{"facility":127,"status":59,"city":128,"state":129,"zip":130,"country":63,"countryCode":64,"cosmosGeoPoint":131,"geoPoint":135,"contacts":40},"Northwell Health\u002FMonter Cancer Center","Lake Success","New York","11042",{"type":66,"coordinates":132},[133,134],-73.71763,40.77066,{"lat":134,"lon":133},{"facility":137,"status":92,"city":138,"state":129,"zip":139,"country":63,"countryCode":64,"cosmosGeoPoint":140,"geoPoint":144,"contacts":40},"Mainstreet Physicans Care","Rochester","14642",{"type":66,"coordinates":141},[142,143],-77.61556,43.15478,{"lat":143,"lon":142},{"facility":146,"status":59,"city":147,"state":148,"zip":149,"country":63,"countryCode":64,"cosmosGeoPoint":150,"geoPoint":154,"contacts":40},"Precision Cancer Research\u002FDayton Physicians Network - Treatment","Kettering","Ohio","45409",{"type":66,"coordinates":151},[152,153],-84.16883,39.6895,{"lat":153,"lon":152},{"facility":156,"status":92,"city":157,"state":158,"zip":159,"country":63,"countryCode":64,"cosmosGeoPoint":160,"geoPoint":164,"contacts":40},"Oregon Health and Science University","Portland","Oregon","97239",{"type":66,"coordinates":161},[162,163],-122.67621,45.52345,{"lat":163,"lon":162},{"facility":166,"status":92,"city":167,"state":168,"zip":169,"country":63,"countryCode":64,"cosmosGeoPoint":170,"geoPoint":174,"contacts":40},"St. Luke's Hospital","Easton","Pennsylvania","18045",{"type":66,"coordinates":171},[172,173],-75.22073,40.68843,{"lat":173,"lon":172},{"facility":176,"status":92,"city":177,"state":178,"zip":179,"country":63,"countryCode":64,"cosmosGeoPoint":180,"geoPoint":184,"contacts":40},"HOPE Cancer Center of East Texas","Tyler","Texas","75701",{"type":66,"coordinates":181},[182,183],-95.30106,32.35126,{"lat":183,"lon":182},{"facility":186,"status":59,"city":187,"state":188,"zip":189,"country":63,"countryCode":64,"cosmosGeoPoint":190,"geoPoint":194,"contacts":40},"Medical Oncology Associates, PS (dba Summit Cancer Centers)","Spokane","Washington","99208",{"type":66,"coordinates":191},[192,193],-117.42908,47.65966,{"lat":193,"lon":192},{"facility":196,"status":197,"city":198,"state":40,"zip":199,"country":200,"countryCode":201,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Beijing Cancer Hospital","RECRUITING","Beijing","100142","China","CN",{"type":66,"coordinates":203},[204,205],116.39723,39.9075,{"lat":205,"lon":204},[208],{"name":209,"role":51,"phone":210,"phoneExt":40,"email":211},"Bixia Tang, MD, PhD","13810211044","bixiatang_med@126.com",{"facility":213,"status":214,"city":215,"state":40,"zip":216,"country":200,"countryCode":201,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"Zhongshan Hospital Affiliated to Fudan University","NOT_YET_RECRUITING","Shanghai","200032",{"type":66,"coordinates":218},[219,220],121.45806,31.22222,{"lat":220,"lon":219},[223],{"name":224,"role":51,"phone":225,"phoneExt":40,"email":226},"Xiaoyi Hu, MD, PhD","13917166233","hu.xiaoyi@zs-hospital.sh.cn",{"facility":228,"status":59,"city":229,"state":40,"zip":230,"country":231,"countryCode":232,"cosmosGeoPoint":233,"geoPoint":237,"contacts":40},"Fondazione del Piemonte per l'Oncologia_Istituto di Candiolo, IRCCS_ Oncologia Medica","Candiolo","10060","Italy","IT",{"type":66,"coordinates":234},[235,236],7.59812,44.95858,{"lat":236,"lon":235},{"facility":239,"status":59,"city":240,"state":40,"zip":241,"country":231,"countryCode":232,"cosmosGeoPoint":242,"geoPoint":246,"contacts":40},"A.O. Cannizzaro_UOS Oncologia Medica","Catania","95126",{"type":66,"coordinates":243},[244,245],15.07041,37.49223,{"lat":245,"lon":244},{"facility":248,"status":59,"city":249,"state":40,"zip":250,"country":231,"countryCode":232,"cosmosGeoPoint":251,"geoPoint":255,"contacts":40},"IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) UO Oncologia Medica","Meldola (FC)","47014",{"type":66,"coordinates":252},[253,254],12.0626,44.12775,{"lat":254,"lon":253},{"facility":257,"status":59,"city":258,"state":40,"zip":259,"country":231,"countryCode":232,"cosmosGeoPoint":260,"geoPoint":264,"contacts":40},"Istituto Europeo di Oncologia_Unità Oncologia Medica Urogenitale e Cervico Facciale","Milan","20141",{"type":66,"coordinates":261},[262,263],12.59836,42.78235,{"lat":263,"lon":262},{"facility":266,"status":59,"city":267,"state":40,"zip":268,"country":231,"countryCode":232,"cosmosGeoPoint":269,"geoPoint":273,"contacts":40},"Istituto Nazionale dei Tumori-Fondazione Pascale- SC Oncologia Medica","Naples","80131",{"type":66,"coordinates":270},[271,272],14.26811,40.85216,{"lat":272,"lon":271},{"facility":275,"status":59,"city":276,"state":40,"zip":277,"country":231,"countryCode":232,"cosmosGeoPoint":278,"geoPoint":282,"contacts":40},"Azienda Ospedaliero-Universitaria Maggiore della Carità Novara_SC Oncologia Medica","Novara","28100",{"type":66,"coordinates":279},[280,281],8.62118,45.44694,{"lat":281,"lon":280},{"facility":284,"status":59,"city":285,"state":40,"zip":286,"country":231,"countryCode":232,"cosmosGeoPoint":287,"geoPoint":291,"contacts":40},"Istituti Clinici Scientifici Maugeri Spa-SB_ UO Oncologia Medica","Pavia","27100",{"type":66,"coordinates":288},[289,290],9.15917,45.19205,{"lat":290,"lon":289},{"facility":293,"status":59,"city":294,"state":40,"zip":295,"country":231,"countryCode":232,"cosmosGeoPoint":296,"geoPoint":300,"contacts":40},"Azienda Ospedaliero Universitaria Pisana_ UO Oncologia Medica Universitaria","Pisa","56126",{"type":66,"coordinates":297},[298,299],10.4036,43.70853,{"lat":299,"lon":298},{"facility":302,"status":59,"city":303,"state":40,"zip":304,"country":231,"countryCode":232,"cosmosGeoPoint":305,"geoPoint":309,"contacts":40},"Fondazione Policlinico Universitario A. Gemelli, U.O.C. Oncologia Medica","Roma","'00168",{"type":66,"coordinates":306},[307,308],11.10642,44.99364,{"lat":308,"lon":307},{"facility":311,"status":59,"city":312,"state":40,"zip":313,"country":314,"countryCode":315,"cosmosGeoPoint":316,"geoPoint":320,"contacts":40},"Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny","Brzozów","36-200","Poland","PL",{"type":66,"coordinates":317},[318,319],22.01926,49.69501,{"lat":319,"lon":318},{"facility":322,"status":59,"city":323,"state":40,"zip":324,"country":314,"countryCode":315,"cosmosGeoPoint":325,"geoPoint":329,"contacts":40},"Szpitale Pomorskie Sp. z o.o. Oddział Onkologii i Radioterapii","Gdynia","81-519",{"type":66,"coordinates":326},[327,328],18.53188,54.51889,{"lat":328,"lon":327},{"facility":331,"status":92,"city":332,"state":40,"zip":333,"country":314,"countryCode":315,"cosmosGeoPoint":334,"geoPoint":338,"contacts":40},"Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. Oddział Onkologii Klinicznej z Pododdziałem Dziennym","Krakow","31-826",{"type":66,"coordinates":335},[336,337],19.93658,50.06143,{"lat":337,"lon":336},{"facility":340,"status":59,"city":341,"state":40,"zip":342,"country":314,"countryCode":315,"cosmosGeoPoint":343,"geoPoint":347,"contacts":40},"Clinical Research Center Sp. z o.o., Medic-R Sp. K.","Poznan","60-848",{"type":66,"coordinates":344},[345,346],16.92993,52.40692,{"lat":346,"lon":345},{"facility":349,"status":92,"city":350,"state":40,"zip":351,"country":352,"countryCode":40,"cosmosGeoPoint":353,"geoPoint":357,"contacts":40},"National Cancer Center - Center For Prostate Cancer","Goyang-si","10408","South Korea",{"type":66,"coordinates":354},[355,356],126.835,37.65639,{"lat":356,"lon":355},{"facility":359,"status":92,"city":360,"state":40,"zip":361,"country":352,"countryCode":40,"cosmosGeoPoint":362,"geoPoint":366,"contacts":40},"CHA Bundang Medical Center, CHA University","Seongnam-si","13496",{"type":66,"coordinates":363},[364,365],127.13778,37.43861,{"lat":365,"lon":364},{"facility":368,"status":92,"city":369,"state":40,"zip":370,"country":352,"countryCode":40,"cosmosGeoPoint":371,"geoPoint":375,"contacts":40},"Severance Hospital, Yonsei University Health System - Medical Oncology","Seoul","03722",{"type":66,"coordinates":372},[373,374],126.9784,37.566,{"lat":374,"lon":373},{"facility":377,"status":92,"city":369,"state":40,"zip":378,"country":352,"countryCode":40,"cosmosGeoPoint":379,"geoPoint":381,"contacts":40},"Asan Medical Center - University of Ulsan College of Medicin","05505",{"type":66,"coordinates":380},[373,374],{"lat":374,"lon":373},{"facility":383,"status":59,"city":369,"state":40,"zip":384,"country":352,"countryCode":40,"cosmosGeoPoint":385,"geoPoint":387,"contacts":40},"Samsung Medical Center - Hematology-Oncology","06351",{"type":66,"coordinates":386},[373,374],{"lat":374,"lon":373},{"facility":389,"status":59,"city":390,"state":40,"zip":391,"country":392,"countryCode":393,"cosmosGeoPoint":394,"geoPoint":398,"contacts":40},"H.G.U. de Elche","Elche","03203","Spain","ES",{"type":66,"coordinates":395},[396,397],-0.70107,38.26218,{"lat":397,"lon":396},{"facility":400,"status":59,"city":401,"state":40,"zip":402,"country":392,"countryCode":393,"cosmosGeoPoint":403,"geoPoint":407,"contacts":40},"Hospital Universitario Fundación Jiménez Díaz","Madrid","28040",{"type":66,"coordinates":404},[405,406],-3.70256,40.4165,{"lat":406,"lon":405},{"facility":409,"status":92,"city":401,"state":40,"zip":410,"country":392,"countryCode":393,"cosmosGeoPoint":411,"geoPoint":413,"contacts":40},"Hospital Universitario 12 de Octubre","28041",{"type":66,"coordinates":412},[405,406],{"lat":406,"lon":405},{"facility":415,"status":59,"city":416,"state":40,"zip":417,"country":392,"countryCode":393,"cosmosGeoPoint":418,"geoPoint":422,"contacts":40},"H.U. Virgen de la Victoria","Málaga","29010",{"type":66,"coordinates":419},[420,421],-4.42034,36.72016,{"lat":421,"lon":420},{"type":424,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100331224","phase-3-a-study-of-pazopanib-with-or-without-abexinostat-in-patients-with-locally-advanced-or-metastatic-renal-cell-carcinoma-renaviv-100331224",false,"NCT03592472","A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)","A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma(RENAVIV)","Inclusion Criteria:\n\nTo be enrolled in the study, patients will be required to meet all of the following criteria:\n\n* Patients aged ≥ 18 years at time of study entry.\n* Patients have histologically confirmed RCC with clear cell component.\n* Patients have locally advanced and unresectable or metastatic disease.\n* Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.\n* Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced\u002Fmetastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.\n* Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Patients have adequate baseline organ function.\n* Patients have adequate baseline hematologic function\n* Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria at Screening will not be enrolled in the study:\n\n* Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).\n* Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated.\n* Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.\n* Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.\n* A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.\n* Has a QTcF interval \\> 480 msec.\n* New York Heart Association Class III or IV congestive heart failure.\n* Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.","ALL","18 Years",{"count":435,"type":436},413,"ESTIMATED","INTERVENTIONAL",[439],"PHASE3","This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).",[442],"Renal Cell Carcinoma",[442,444,30,24,445,446],"Progression-free survival","RECIST","Cancer therapy","2025-04-09",{"date":449,"type":450},"2025-04-13","ACTUAL",{"date":452,"type":450},"2018-07-17",{"date":454,"type":436},"2028-06-30",{"name":5,"class":6},38]