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Antonio","78229",{"type":72,"coordinates":658},[659,660],-98.49363,29.42412,{"lat":660,"lon":659},[663,667],{"name":664,"role":59,"phone":665,"phoneExt":55,"email":666},"Leti Velten","210-450-1921","velten@uthscsa.edu",{"name":668,"role":84,"phone":55,"phoneExt":55,"email":55},"Andrew Brenner, MD",{"facility":670,"status":65,"city":671,"state":672,"zip":673,"country":69,"countryCode":70,"cosmosGeoPoint":674,"geoPoint":678,"contacts":679},"Huntsman Cancer Insititute, University of Utah","Salt Lake City","Utah","84112",{"type":72,"coordinates":675},[676,677],-111.89105,40.76078,{"lat":677,"lon":676},[680,684],{"name":681,"role":59,"phone":682,"phoneExt":55,"email":683},"Neuro Oncology Coordination","801-585-0115","neurooncologycoordinationsstaff@hci.utah.edu",{"name":685,"role":84,"phone":55,"phoneExt":55,"email":55},"Howard Colman, MD",{"facility":687,"status":65,"city":688,"state":689,"zip":690,"country":69,"countryCode":70,"cosmosGeoPoint":691,"geoPoint":695,"contacts":696},"UVA Health, Emily Couric Clinical Cancer Cente","Charlottesville","Virginia","22903",{"type":72,"coordinates":692},[693,694],-78.47668,38.02931,{"lat":694,"lon":693},[697,700],{"name":698,"role":59,"phone":55,"phoneExt":55,"email":699},"CJ Woodburn, 434-243-9900","cjw4v@virginia.edu",{"name":701,"role":84,"phone":55,"phoneExt":55,"email":55},"David Schiff, M.D.",{"facility":703,"status":116,"city":704,"state":689,"zip":705,"country":69,"countryCode":70,"cosmosGeoPoint":706,"geoPoint":710,"contacts":711},"Inova Schar Cancer Institute","Fairfax","22031",{"type":72,"coordinates":707},[708,709],-77.30637,38.84622,{"lat":709,"lon":708},[712,716],{"name":713,"role":59,"phone":714,"phoneExt":55,"email":715},"Stephanie Van Bebber","571-472-4724","stephanie.vanbebber@inova.org",{"name":717,"role":84,"phone":55,"phoneExt":55,"email":55},"Adam Cohen, MD",{"facility":719,"status":65,"city":720,"state":721,"zip":722,"country":69,"countryCode":70,"cosmosGeoPoint":723,"geoPoint":727,"contacts":728},"Fred Hutch Cancer Center","Seattle","Washington","98195",{"type":72,"coordinates":724},[725,726],-122.33207,47.60621,{"lat":726,"lon":725},[729,733],{"name":730,"role":59,"phone":731,"phoneExt":55,"email":732},"Madhuri Poduri","206-667-3691","mpoduri@fredhutch.org",{"name":734,"role":84,"phone":55,"phoneExt":55,"email":55},"Vyshak Venur, MD",{"facility":736,"status":65,"city":737,"state":738,"zip":739,"country":69,"countryCode":70,"cosmosGeoPoint":740,"geoPoint":744,"contacts":745},"University of Wisconsin Health","Madison","Wisconsin","53792",{"type":72,"coordinates":741},[742,743],-89.40123,43.07305,{"lat":743,"lon":742},[746,750],{"name":747,"role":59,"phone":748,"phoneExt":55,"email":749},"UW Cancer Connect","800-622-8922","cancerconnect@uwhealth.org",{"name":751,"role":84,"phone":55,"phoneExt":55,"email":55},"Ankush Bhatia, MD",{"facility":753,"status":65,"city":754,"state":755,"zip":55,"country":756,"countryCode":757,"cosmosGeoPoint":758,"geoPoint":762,"contacts":763},"St Vincents Hospital Sydney (Kinghorn)","Darlinghurst","New South Wales","Australia","AU",{"type":72,"coordinates":759},[760,761],151.21925,-33.87939,{"lat":761,"lon":760},[764,768],{"name":765,"role":59,"phone":766,"phoneExt":55,"email":767},"Ashley Douglas","02 9355 5613","ashley.douglas@svha.org.au",{"name":769,"role":84,"phone":55,"phoneExt":55,"email":55},"Subotheni Thavaneswaran, MD",{"facility":771,"status":65,"city":772,"state":755,"zip":55,"country":756,"countryCode":757,"cosmosGeoPoint":55,"geoPoint":55,"contacts":773},"Royal North Shore Hospital","Saint Leonards",[774,778],{"name":775,"role":59,"phone":776,"phoneExt":55,"email":777},"Sally McCowatt","02 9463 1181","sally.mccowatt@health.nsw.gov.au",{"name":779,"role":84,"phone":55,"phoneExt":55,"email":55},"Helen Wheeler, MD",{"facility":781,"status":65,"city":782,"state":783,"zip":55,"country":756,"countryCode":757,"cosmosGeoPoint":784,"geoPoint":788,"contacts":789},"Royal Brisbane and Women's Hospital","Herston","Queensland",{"type":72,"coordinates":785},[786,787],153.01852,-27.44453,{"lat":787,"lon":786},[790,794],{"name":791,"role":59,"phone":792,"phoneExt":55,"email":793},"Amy Ives","07 3646 7712","Amy.Ives@health.qld.gov.au",{"name":795,"role":84,"phone":55,"phoneExt":55,"email":55},"Zarnie Lwin, MD",{"facility":797,"status":65,"city":798,"state":799,"zip":55,"country":756,"countryCode":757,"cosmosGeoPoint":800,"geoPoint":804,"contacts":805},"Peter MacCallum Cancer Centre","Melbourne","Victoria",{"type":72,"coordinates":801},[802,803],144.96332,-37.814,{"lat":803,"lon":802},[806,810],{"name":807,"role":59,"phone":808,"phoneExt":55,"email":809},"Clinical Trial Team (Monc A Team)","(03) 8559 5000","PCCTU.MoncA@petermac.org",{"name":811,"role":84,"phone":55,"phoneExt":55,"email":55},"Jim Whittle, MD",{"facility":813,"status":65,"city":798,"state":799,"zip":55,"country":756,"countryCode":757,"cosmosGeoPoint":814,"geoPoint":816,"contacts":817},"The Alfred",{"type":72,"coordinates":815},[802,803],{"lat":803,"lon":802},[818,822],{"name":819,"role":59,"phone":820,"phoneExt":55,"email":821},"Lucy Gately, MD","03 9076 3129","l.gately@alfred.org.au",{"name":819,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":824,"status":116,"city":825,"state":826,"zip":827,"country":756,"countryCode":757,"cosmosGeoPoint":828,"geoPoint":832,"contacts":833},"Sir Charles Gairdner Hospital","Nedlands","Western Australia","6009",{"type":72,"coordinates":829},[830,831],115.8073,-31.98184,{"lat":831,"lon":830},[834,838],{"name":835,"role":59,"phone":836,"phoneExt":55,"email":837},"Wee Chin, MD","61 6457 3333","wee.chin@health.wa.gov.au",{"name":835,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":840,"status":65,"city":841,"state":842,"zip":843,"country":844,"countryCode":845,"cosmosGeoPoint":846,"geoPoint":850,"contacts":851},"Beijing Tiantan Hospital, Capital Medical University","Beijing","Beijing Municipality","100070","China","CN",{"type":72,"coordinates":847},[848,849],116.39723,39.9075,{"lat":849,"lon":848},[852,856],{"name":853,"role":59,"phone":854,"phoneExt":55,"email":855},"Xiaohui Ren, MD","15011450618","xiaohuiren@aliyun.com",{"name":853,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":858,"status":65,"city":841,"state":842,"zip":859,"country":844,"countryCode":845,"cosmosGeoPoint":860,"geoPoint":862,"contacts":863},"Sanbo Brain Hospital, Capital Medical University","100093",{"type":72,"coordinates":861},[848,849],{"lat":849,"lon":848},[864,868],{"name":865,"role":59,"phone":866,"phoneExt":55,"email":867},"Junping Zhang, MD","13811099759","doczhjp@hotmail.com",{"name":865,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":870,"status":65,"city":841,"state":842,"zip":871,"country":844,"countryCode":845,"cosmosGeoPoint":872,"geoPoint":874,"contacts":875},"Xuanwu Hospital, Capital Medical University","10053",{"type":72,"coordinates":873},[848,849],{"lat":849,"lon":848},[876,880],{"name":877,"role":59,"phone":878,"phoneExt":55,"email":879},"Qingtang Lin, MD","15801588169","linqingtang@xwhosp.org",{"name":877,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":882,"status":65,"city":841,"state":842,"zip":883,"country":844,"countryCode":845,"cosmosGeoPoint":884,"geoPoint":886,"contacts":887},"Peking Union Medical College Hospital","100730",{"type":72,"coordinates":885},[848,849],{"lat":849,"lon":848},[888,892],{"name":889,"role":59,"phone":890,"phoneExt":55,"email":891},"Wenbin Ma, MD","13701364566","mawb@pumch.cn",{"name":889,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":894,"status":65,"city":895,"state":896,"zip":897,"country":844,"countryCode":845,"cosmosGeoPoint":898,"geoPoint":902,"contacts":903},"The First Affiliated Hospital of Fujian Medical University","Fuzhou","Fujian","350005",{"type":72,"coordinates":899},[900,901],119.30611,26.06139,{"lat":901,"lon":900},[904,908],{"name":905,"role":59,"phone":906,"phoneExt":55,"email":907},"Dezhi Kang, MD","0591-87982123","kdz99988@sina.com",{"name":905,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":910,"status":65,"city":911,"state":912,"zip":913,"country":844,"countryCode":845,"cosmosGeoPoint":914,"geoPoint":918,"contacts":919},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":72,"coordinates":915},[916,917],113.25,23.11667,{"lat":917,"lon":916},[920,924],{"name":921,"role":59,"phone":922,"phoneExt":55,"email":923},"Zhongping Chen, MD","020-87343310","chenzhp@sysucc.org.cn",{"name":921,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":926,"status":65,"city":927,"state":928,"zip":929,"country":844,"countryCode":845,"cosmosGeoPoint":930,"geoPoint":934,"contacts":935},"Xiangya Hospital of Central South University","Changsha","Hunan","410008",{"type":72,"coordinates":931},[932,933],112.97087,28.19874,{"lat":933,"lon":932},[936,940],{"name":937,"role":59,"phone":938,"phoneExt":55,"email":939},"Zhixiong Liu, MD","13607318785","zhixiongliu@csu.edu.cn",{"name":937,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":942,"status":65,"city":943,"state":944,"zip":945,"country":844,"countryCode":845,"cosmosGeoPoint":946,"geoPoint":950,"contacts":951},"Huashan Hospital Affiliated to Fudan University","Shanghai","Shanghai Municipality","200040",{"type":72,"coordinates":947},[948,949],121.45806,31.22222,{"lat":949,"lon":948},[952,956],{"name":953,"role":59,"phone":954,"phoneExt":55,"email":955},"Ying Mao, MD","13801769152","my_gcp@sina.com",{"name":953,"role":84,"phone":55,"phoneExt":55,"email":55},{"facility":958,"status":65,"city":959,"state":960,"zip":961,"country":844,"countryCode":845,"cosmosGeoPoint":962,"geoPoint":966,"contacts":967},"West China Hospital of Sichuan University","Chengdu","Sichuan","610041",{"type":72,"coordinates":963},[964,965],104.06667,30.66667,{"lat":965,"lon":964},[968,972],{"name":969,"role":59,"phone":970,"phoneExt":55,"email":971},"Yanhui Liu, MD","18980601509","liuyh@scu.edu.com",{"name":969,"role":84,"phone":55,"phoneExt":55,"email":55},{"type":974,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[976],{"name":977,"class":6},"AnHeart Therapeutics Inc.","100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580",false,"NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days and no longer than 5 years before the date of enrollment, have not had any other prior anticancer therapy, including chemotherapy and radiotherapy, and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.","ALL","18 Years",{"count":989,"type":990},365,"ESTIMATED","INTERVENTIONAL",[993],"PHASE3","This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[996,997,998,999,1000,1001,1002,1003],"Glioma","Astrocytoma, Grade IV","IDH1-mutant Glioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[46,1005,1006],"IDH1-mutant glioma","astrocytoma","2026-06-29",{"date":1009,"type":1010},"2026-07-01","ACTUAL",{"date":1012,"type":1010},"2023-06-05",{"date":1014,"type":990},"2030-12-01",{"name":5,"class":6},57]