[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360233":3},{"organization":4,"armGroups":7,"interventions":89,"overallOfficials":159,"centralContacts":164,"locations":173,"responsibleParty":1142,"collaborators":1144,"id":1163,"slug":119,"hasResults":1164,"nctId":1165,"briefTitle":1166,"officialTitle":1167,"acronym":1168,"eligibilityCriteria":1169,"healthyVolunteers":1164,"sex":1170,"minAge":1171,"maxAge":119,"enrollmentInfo":1172,"targetDuration":119,"studyType":1175,"phases":1176,"briefSummary":1179,"conditions":1180,"keywords":1182,"overallStatus":176,"whyStopped":119,"lastUpdateSubmitDate":1194,"lastUpdatePostDateStruct":1195,"startDateStruct":1198,"completionDateStruct":1200,"leadSponsor":1202,"locationsCount":1203},{"fullName":5,"class":6},"Global Coalition for Adaptive Research","OTHER",[8,16,22,27,32,37,41,45,50,54,58,63,67,71,76,81,85],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","ACTIVE_COMPARATOR","Newly Diagnosed GBM: Radiation therapy (XRT) 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily during radiation therapy. Rest Period 2-6 weeks from the last day of radiation, and the start of the first cycle of Maintenance Therapy 2-6 weeks after the last day of radiotherapy. The start of all subsequent maintenance therapy cycles (2-12) every 4 weeks + 7 days after the first daily dose of temozolomide of the preceding cycle. Total number of cycles should comply with institutional or country standards. During maintenance therapy, the first cycle of temozolomide will be at 150 mg\u002Fm2 for Days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg\u002Fm2 for Days 1-5 of a 28-day cycle.\n\nRecurrent GBM: Lomustine started at 110 mg\u002Fm2\u002Fday on Day 1 of a 42-day cycle as per local standards. Treatment will continue for up to 6 total cycles.",[13,14,15],"Drug: Temozolomide","Drug: Lomustine","Radiation: Radiation",{"label":17,"type":18,"description":19,"interventionNames":20},"Regorafenib Treatment Arm- Enrollment concluded","EXPERIMENTAL","Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).\n\nRecurrent GBM: Regorafenib (Dosage Form: Tablet for oral administration; Strength: 40 mg) 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).",[21],"Drug: Regorafenib",{"label":23,"type":18,"description":24,"interventionNames":25},"Paxalisib Treatment Arm- Enrollment concluded","Newly Diagnosed MGMT Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles.\n\nRecurrent GBM: Paxalisib (Dosage Form: Tablet for oral administration; Strength: 15 mg per tablet) 45 mg orally (PO) every day for 21 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 21 days for all subsequent cycles.",[26],"Drug: Paxalisib",{"label":28,"type":18,"description":29,"interventionNames":30},"VAL-083 Treatment Arm- Enrollment concluded","Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily during radiation therapy. Rest Period 4 weeks from the last day of radiation. Maintenance period: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg\u002Fm2) on Day 1, 2 and 3 of 21-day cycle.\n\nRecurrent GBM: VAL-083 (Dosage Form: Infusion for intravenous administration; Strength: 30 mg\u002Fm2) on Day 1, 2 and 3 of 21-day cycle.",[31],"Drug: VAL-083",{"label":33,"type":18,"description":34,"interventionNames":35},"VT1021 Treatment Arm - Dose Finding Phase","Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. Treatment as outlined in section \"Experimental: VT1021 Treatment Arm\" with the first 6 patients receiving VT1021 at 12 mg\u002Fkg twice weekly in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities reported, the dose will be de-escalated to 9 mg\u002Fkg two times a week. 6 patients will then be receiving 9 mg\u002Fkg two times a week and observed for DLTs for 4 weeks.\n\nRecurrent GBM: Dose Finding Phase is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.",[36],"Drug: VT1021",{"label":38,"type":18,"description":39,"interventionNames":40},"VT1021 Treatment Arm - Enhanced Safety Management (ESM)","Experimental: VT1021 Treatment Arm - Enhanced Safety Management (ESM) Newly diagnosed MGMT Methylated and Unmethylated GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. PK and PD assessments are done for patients as a part of ESM. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.\n\nRecurrent GBM: ESM is not applicable for patients with Recurrent GBM in the VT1021 treatment arm.",[36],{"label":42,"type":18,"description":43,"interventionNames":44},"VT1021 Treatment Arm","Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily and VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg\u002FmL; Dose: As confirmed through the dose finding phase) twice weekly during radiation therapy. Rest period: 2-6 weeks from last day of radiation. VT1021 dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg\u002Fm2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg\u002Fm2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with VT1021. After 6 cycles, VT1021 only.\n\nRecurrent GBM: VT1021 (Dosage Form: Infusion for intravenous administration; Strength: 10 mg\u002FmL; Dose: 12mg\u002Fkg) twice weekly.",[36],{"label":46,"type":18,"description":47,"interventionNames":48},"Troriluzole Treatment Arm - Dose Finding Phase","Newly diagnosed MGMT Methylated and Unmethylated GBM: Rolling 6 design. The first 6 patients will receive troriluzole at 100 mg BID for the first two weeks followed by 200 mg BID for the next two weeks in combination with temozolomide and radiation therapy. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 100 mg in the morning and followed by 200 mg in the evening. 6 patients will receive this dose and observed for 4 weeks. If there are two DLTs reported, then this dose will be de-escalated to 100 mg BID. 6 patients will then be receiving this dose and observed for DLTs for 4 weeks.\n\nRecurrent GBM: Rolling 6 design. The first 6 patients receiving troriluzole 100 mg twice a day (BID) for the first two weeks followed by 200 mg BID for the next two weeks in combination with lomustine. The dose de-escalation is similar to that of newly diagnosed patients during the rolling 6 design.",[49],"Drug: Troriluzole",{"label":51,"type":18,"description":52,"interventionNames":53},"Troriluzole Treatment Arm - Enhanced Safety Management (ESM)","Newly diagnosed MGMT Methylated and Unmethylated GBM and Recurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.",[49],{"label":55,"type":18,"description":56,"interventionNames":57},"Troriluzole Treatment Arm","Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily and troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. Rest period: 2-6 weeks from last day of radiation. Troriluzole dosing will continue during the rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg\u002Fm2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg\u002Fm2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with troriluzole. After 6 cycles, troriluzole only.\n\nRecurrent GBM: Lomustine 100 mg\u002Fm2 orally on day 1 of a 42-day cycle in combination with troriluzole (Dosage Form: Capsule for oral administration; Strength: 100 mg; Dose: As confirmed by dose finding phase) BID. After 6 cycles, troriluzole only.",[49],{"label":59,"type":18,"description":60,"interventionNames":61},"ADI-PEG 20 Treatment Arm - Dose Finding Phase","Newly diagnosed MGMT Methylated and Unmethylated GBM: Dose Finding Phase is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm.\n\nRecurrent GBM: Rolling 6 design. The first 6 patients will receive ADI-PEG 20 at 36 mg\u002Fm2 once a week in combination with lomustine 100 mg\u002Fm2 orally on day 1 of a 42-day cycle. 6 patients will receive this dose and be observed for 4 weeks. If there are two dose limiting toxicities (DLTs) reported, the dose will be de-escalated to 18 mg\u002Fm2 once a week. 6 patients will receive this dose and be observed for 4 weeks.",[62],"Biological: ADI-PEG 20",{"label":64,"type":18,"description":65,"interventionNames":66},"ADI-PEG 20 Treatment Arm - Enhanced Safety Management (ESM)","Newly diagnosed MGMT Methylated and Unmethylated GBM: ESM is not applicable for newly diagnosed patients on the ADI-PEG 20 treatment arm.\n\nRecurrent GBM: Supplemental safety assessments including bi-weekly collection of adverse events, dose modification profile, hematology, serum chemistry and coagulation panels. ESM will continue until the Data Safety Monitoring Board (DSMB) suspends collection of additional data.",[62],{"label":68,"type":18,"description":69,"interventionNames":70},"ADI-PEG 20 Treatment Arm","Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy over 6 weeks. Temozolomide (75 mg\u002Fm2 orally daily and ADI-PEG 20 (Dosage Form: Solution for intramuscular injection; Strength: 11.5 ± 1.0 mg\u002Fml; Dose: 36 mg\u002Fm2) once a week. Rest period: 2-6 weeks from last day of radiation. ADI-PEG 20 dosing will continue during rest period. Maintenance period: The first cycle of temozolomide will be at 150 mg\u002Fm2 for days 1-5 of a 28-day cycle. Subsequent cycles will be at 200 mg\u002Fm2 for days 1-5 of a 28-day cycle. Temozolomide will be administered for up to 6 cycles in the maintenance phase in combination with ADI-PEG 20. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment.\n\nRecurrent GBM: Lomustine 100 mg\u002Fm2 orally on day 1 of a 42-day cycle in combination with ADI-PEG 20 (Dosage Form: Solution for IM injection; Strength: 11.5 ± 1.0 mg\u002Fml; Dose: As confirmed by dose finding phase, once a week. After 6 cycles, ADI-PEG 20 only for up to 104 weeks of total treatment.",[62],{"label":72,"type":18,"description":73,"interventionNames":74},"AZD1390 Treatment Arm","Newly Diagnosed MGMT Methylated and Unmethylated GBM: XRT 60 Gy for 6 weeks in combination with AZD1390 given on days of radiation followed by 14 days with daily AZD1390. Rest Period 2-4 weeks from the last day of AZD1390. The first cycle of temozolomide will be at 150 mg\u002Fm2 for days 1-5 of a 28-day cycle. Second and subsequent cycles of maintenance therapy will be at 200 mg\u002Fm2 for days 1-5 of a 28-day cycle, if there is no toxicity. Temozolomide will be administered for up to 6 cycles in the maintenance phase.",[75],"Drug: AZD1390",{"label":77,"type":18,"description":78,"interventionNames":79},"Tinostamustine - Dose finding phase","Newly diagnosed MGMT Methylated and Unmethylated GBM: Tinostamustine Dosage Form: Infusion for intravenous administration; Rolling 6 design. Treatment as outlined in \"Investigational: Tinostamustine Treatment Arm\" with the first 6 patients receiving Tinostamustine at 80 mg\u002Fm2 over 60 minutes with two potential dose de-escalations. If there are two or more dose limiting toxicities at the tested dose, subsequent patients will be enrolled at the next lower dose level (60 mg\u002Fm2 and subsequently to 40 mg\u002Fm2).\n\nRecurrent GBM: Rolling 6 design. Tinostamustine Dosage Form: Infusion for intravenous administration; Strength: Starting dose 80 mg\u002Fm2 on Day 1 of 21-day cycle for up to 12 cycles. The first 6 patients will receive Tinostamustine at 80 mg\u002Fm2 over 60 minutes with two potential dose de-escalations if there are two or more dose limiting toxicities at the tested dose, subsequent patients will be enrolled at the next lower dose level (60 mg\u002Fm2 and subsequently to 40 mg\u002Fm2).",[80],"Drug: Tinostamustine",{"label":82,"type":18,"description":83,"interventionNames":84},"Tinostamustine - Enhanced Safety Management","Newly diagnosed MGMT Methylated and Unmethylated GBM: Treatment as outlined in \"Investigational: Tinostamustine Treatment Arm\". Dose as determined by the dose finding phase.\n\nRecurrent GBM: Tinostamustine (Dosage Form: Infusion for intravenous administration; Strength: as determined though the dose finding phase on Day 1 of 21-day cycle for up to 12 cycles.",[80],{"label":86,"type":18,"description":87,"interventionNames":88},"Investigation arm: Tinostamustine","Newly diagnosed MGMT Methylated and Unmethylated GBM: XRT total of 60 Gy (2 Gy\u002Ffraction) over 6 weeks. Temozolomide 75 mg\u002Fm2 orally daily during radiation therapy. Rest Period 2-6 weeks from the last day of radiation. Tinostamustine treatment period: Tinostamustine (Dosage Form: Infusion for intravenous administration; Strength: as determined though the dose finding phase) on Day 1 of 21-day cycle for up to 12 cycles.",[80],[90,99,107,114,120,126,132,136,142,149,153],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"DRUG","Temozolomide","Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg",[9],[96,97,98],"Temodar","Temodal","Temcad",{"type":91,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Lomustine","Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg",[9],[104,105,106],"CCNU","CeeNU","Gleostine",{"type":91,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"Regorafenib","Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)",[17],[112,113],"Stivarga","BAY 73-4506",{"type":115,"name":116,"description":117,"armGroupLabels":118,"otherNames":119},"RADIATION","Radiation","60 Gy",[9],null,{"type":91,"name":121,"description":122,"armGroupLabels":123,"otherNames":124},"Paxalisib","Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles",[23],[125],"GDC-0084",{"type":91,"name":127,"description":128,"armGroupLabels":129,"otherNames":130},"VAL-083","Dosage Form: Infusion for intravenous administration Strength: 40 mg per vial Standard Regimen: 30 mg\u002Fm2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg\u002Fm2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.",[28],[131],"Dianhydrogalactitol",{"type":91,"name":133,"description":134,"armGroupLabels":135,"otherNames":119},"VT1021","Dosage Form: Infusion for intravenous administration Strength: 10 mg\u002FmL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).\n\nStandard Regimen Recurrent: 12 mg\u002Fkg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.",[42,33,38],{"type":91,"name":137,"description":138,"armGroupLabels":139,"otherNames":140},"Troriluzole","Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.",[55,46,51],[141],"BHV-4157",{"type":143,"name":144,"description":145,"armGroupLabels":146,"otherNames":147},"BIOLOGICAL","ADI-PEG 20","Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg\u002Fml Standard Regimen: For newly diagnosed patients, 36mg\u002Fm2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week",[68,59,64],[148],"Pegargiminase",{"type":91,"name":150,"description":151,"armGroupLabels":152,"otherNames":119},"AZD1390","Standard Regimen Newly Diagnosed: Given once daily on days of radiation and once daily for 14 consecutive days after completion of radiation.",[72],{"type":91,"name":154,"description":155,"armGroupLabels":156,"otherNames":157},"Tinostamustine","Dosage form: Reconstituted powder for intravenous administration Strength: 2mg\u002FmL Standard Regimen: Dose as confirmed through the dose finding phase, on Day 1 of 21-day cycle for up to 12 cycles in the maintenance phase.",[86,77,82],[158],"EDO-S101",[160],{"name":161,"affiliation":162,"role":163},"Tim Cloughesy, MD","GCAR CMO and GBM AGILE Global PI","PRINCIPAL_INVESTIGATOR",[165,170],{"name":166,"role":167,"phone":168,"phoneExt":119,"email":169},"Patient Information","CONTACT","310-598-3199","patientinfo@gcaresearch.org",{"name":171,"role":167,"phone":119,"phoneExt":119,"email":172},"Rachel Rosenstein-Sisson","RRosenstein.Sisson@GCAResearch.org",[174,199,218,233,246,262,278,288,305,322,332,348,368,389,395,405,426,441,451,467,476,486,496,512,525,537,554,571,587,607,624,634,654,663,680,697,707,716,732,753,770,780,790,809,825,842,859,880,900,924,942,963,972,990,1006,1021,1032,1048,1063,1079,1094,1110,1128],{"facility":175,"status":176,"city":177,"state":178,"zip":179,"country":180,"countryCode":181,"cosmosGeoPoint":182,"geoPoint":187,"contacts":188},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35249","United States","US",{"type":183,"coordinates":184},"Point",[185,186],-86.80249,33.52066,{"lat":186,"lon":185},[189,193,197],{"name":190,"role":167,"phone":191,"phoneExt":119,"email":192},"Thiru Pillay","205-934-1432","Tpillay@uabmc.edu",{"name":194,"role":167,"phone":195,"phoneExt":119,"email":196},"Yantong (Lily) Liu","205-975-2283","yantongliu@uabmc.edu",{"name":198,"role":163,"phone":119,"phoneExt":119,"email":119},"Louis B Nabors, MD",{"facility":200,"status":176,"city":201,"state":202,"zip":203,"country":180,"countryCode":181,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"University of California, San Diego","La Jolla","California","92093",{"type":183,"coordinates":205},[206,207],-117.2742,32.84727,{"lat":207,"lon":206},[210,214,216],{"name":211,"role":167,"phone":212,"phoneExt":119,"email":213},"Sheila Medina","(858) 246-1093","s4medina@health.ucsd.edu",{"name":119,"role":167,"phone":119,"phoneExt":119,"email":215},"Neuro-Onc_CRC@health.ucsd.edu",{"name":217,"role":163,"phone":119,"phoneExt":119,"email":119},"David Piccioni, MD, PhD",{"facility":219,"status":176,"city":220,"state":202,"zip":221,"country":180,"countryCode":181,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute","Los Angeles","90048",{"type":183,"coordinates":223},[224,225],-118.24368,34.05223,{"lat":225,"lon":224},[228,231],{"name":229,"role":167,"phone":119,"phoneExt":119,"email":230},"Shannon Cyhan","GroupCCTOClinicalResearchTeamNeuroOncology@cshs.org",{"name":232,"role":163,"phone":119,"phoneExt":119,"email":119},"Jethro Hu, MD",{"facility":234,"status":176,"city":220,"state":202,"zip":235,"country":180,"countryCode":181,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"University of California, Los Angeles","90095",{"type":183,"coordinates":237},[224,225],{"lat":225,"lon":224},[240,244],{"name":241,"role":167,"phone":242,"phoneExt":119,"email":243},"Quan Li","310-825-1416","quanli@mednet.ucla.edu",{"name":245,"role":163,"phone":119,"phoneExt":119,"email":119},"Phioanh Nghiemphu, MD",{"facility":247,"status":176,"city":248,"state":202,"zip":249,"country":180,"countryCode":181,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"St. Joseph Hospital","Orange","92868",{"type":183,"coordinates":251},[252,253],-117.85311,33.78779,{"lat":253,"lon":252},[256,260],{"name":257,"role":167,"phone":258,"phoneExt":119,"email":259},"Andrea Torres","714-734-6220","andrea.torres@providence.org",{"name":261,"role":163,"phone":119,"phoneExt":119,"email":119},"Lars Anker, MD",{"facility":263,"status":176,"city":264,"state":202,"zip":265,"country":180,"countryCode":181,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"University of California, San Francisco","San Francisco","94143",{"type":183,"coordinates":267},[268,269],-122.41942,37.77493,{"lat":269,"lon":268},[272,276],{"name":273,"role":167,"phone":274,"phoneExt":119,"email":275},"UCSF Neuro Onc New Patient Coordinator","(415) 353-2193","NeuroOncNewPatientCoord@ucsf.edu",{"name":277,"role":163,"phone":119,"phoneExt":119,"email":119},"Nicholas Butowski, MD",{"facility":279,"status":280,"city":281,"state":202,"zip":282,"country":180,"countryCode":181,"cosmosGeoPoint":283,"geoPoint":287,"contacts":119},"Stanford Cancer Center","COMPLETED","Stanford","94305",{"type":183,"coordinates":284},[285,286],-122.16608,37.42411,{"lat":286,"lon":285},{"facility":289,"status":176,"city":290,"state":291,"zip":292,"country":180,"countryCode":181,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"University of Colorado Denver","Aurora","Colorado","80045",{"type":183,"coordinates":294},[295,296],-104.83192,39.72943,{"lat":296,"lon":295},[299,303],{"name":300,"role":167,"phone":301,"phoneExt":119,"email":302},"Katherine Harr","303-724-9693","Katherine.harr@cuanschutz.edu",{"name":304,"role":163,"phone":119,"phoneExt":119,"email":119},"Denise Damek, MD",{"facility":306,"status":176,"city":307,"state":308,"zip":309,"country":180,"countryCode":181,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"Yale Cancer Center \u002F Smilow Cancer Hospital*","New Haven","Connecticut","06511",{"type":183,"coordinates":311},[312,313],-72.92816,41.30815,{"lat":313,"lon":312},[316,320],{"name":317,"role":167,"phone":318,"phoneExt":119,"email":319},"Amy L. Rodriguez","203-785-5702","Amy.rodrigues@yale.edu",{"name":321,"role":163,"phone":119,"phoneExt":119,"email":119},"Nicholas Blondin, MD",{"facility":323,"status":280,"city":324,"state":325,"zip":326,"country":180,"countryCode":181,"cosmosGeoPoint":327,"geoPoint":331,"contacts":119},"Mayo Clinic Cancer Center","Jacksonville","Florida","32224",{"type":183,"coordinates":328},[329,330],-81.65565,30.33218,{"lat":330,"lon":329},{"facility":333,"status":176,"city":334,"state":325,"zip":335,"country":180,"countryCode":181,"cosmosGeoPoint":336,"geoPoint":340,"contacts":341},"Sylvester Comprehensive Cancer Center*","Miami","33136",{"type":183,"coordinates":337},[338,339],-80.19366,25.77427,{"lat":339,"lon":338},[342,346],{"name":343,"role":167,"phone":344,"phoneExt":119,"email":345},"Leonela Wright","305-243-0864","lxw612@med.miami.edu",{"name":347,"role":163,"phone":119,"phoneExt":119,"email":119},"Macarena I De La Fuente, 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Zentrum fuer Neurologie und Psychiatrie","Cologne","50937","Germany","DE",{"type":183,"coordinates":1028},[1029,1030],6.95,50.93333,{"lat":1030,"lon":1029},{"facility":1033,"status":176,"city":1034,"state":119,"zip":1035,"country":1025,"countryCode":1026,"cosmosGeoPoint":1036,"geoPoint":1040,"contacts":1041},"Dr. Senckenbergisches Institut für Neuroonkologie","Frankfurt","60528",{"type":183,"coordinates":1037},[1038,1039],10.53333,49.68333,{"lat":1039,"lon":1038},[1042,1046],{"name":1043,"role":167,"phone":1044,"phoneExt":119,"email":1045},"Michael Ronellenfitsch, MD,PhD","+49(0)69 6301 87711","m.ronellenfitsch@med.uni-frankfurt.de",{"name":1047,"role":163,"phone":119,"phoneExt":119,"email":119},"Michael Ronellenfitsch, MD, PhD",{"facility":1049,"status":176,"city":861,"state":119,"zip":1050,"country":1025,"countryCode":1026,"cosmosGeoPoint":1051,"geoPoint":1055,"contacts":1056},"Universitätsklinik Heidelberg","69120",{"type":183,"coordinates":1052},[1053,1054],8.69079,49.40768,{"lat":1054,"lon":1053},[1057,1062],{"name":1058,"role":167,"phone":1059,"phoneExt":1060,"email":1061},"Antje Wick, MD","+49 (0) 6221-56","7075","antje.wick@med.uni-heidelberg.de",{"name":1058,"role":163,"phone":119,"phoneExt":119,"email":119},{"facility":1064,"status":176,"city":1065,"state":119,"zip":1066,"country":1025,"countryCode":1026,"cosmosGeoPoint":1067,"geoPoint":1071,"contacts":1072},"Universitaetsklinikum Heidelberg - Neurologische Klinik","Mannheim","68167",{"type":183,"coordinates":1068},[1069,1070],8.46694,49.4891,{"lat":1070,"lon":1069},[1073,1077],{"name":1074,"role":167,"phone":1075,"phoneExt":119,"email":1076},"Yvonne Neu","+49 621 383-6801","yvonne.neu@umm.de",{"name":1078,"role":163,"phone":119,"phoneExt":119,"email":119},"Michael Platten, MD",{"facility":1080,"status":176,"city":1081,"state":119,"zip":1082,"country":1025,"countryCode":1026,"cosmosGeoPoint":1083,"geoPoint":1087,"contacts":1088},"Universitätsklinikum Regensburg","Regensburg","93053",{"type":183,"coordinates":1084},[1085,1086],12.10161,49.01513,{"lat":1086,"lon":1085},[1089,1093],{"name":1090,"role":167,"phone":1091,"phoneExt":119,"email":1092},"Peter Hau, MD","+49 (0)941 941-8083","Peter.Hau@ukr.de",{"name":1090,"role":163,"phone":119,"phoneExt":119,"email":119},{"facility":1095,"status":176,"city":1096,"state":119,"zip":1097,"country":1025,"countryCode":1026,"cosmosGeoPoint":1098,"geoPoint":1102,"contacts":1103},"Universitätsklinikum Tübingen","Tübingen","72076",{"type":183,"coordinates":1099},[1100,1101],9.05222,48.52266,{"lat":1101,"lon":1100},[1104,1108],{"name":1105,"role":167,"phone":1106,"phoneExt":119,"email":1107},"Ghazaleh Tabatabai","+49 (0)707 12983269","Ghazaleh.Tabatabai@med.uni-tuebingen.de",{"name":1109,"role":163,"phone":119,"phoneExt":119,"email":119},"Ghazaleh Tabatabai, MD",{"facility":1111,"status":176,"city":1112,"state":1113,"zip":1114,"country":1115,"countryCode":1116,"cosmosGeoPoint":1117,"geoPoint":1121,"contacts":1122},"Centre Hospitalier Universitaire Vaudois Lausanne","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":183,"coordinates":1118},[1119,1120],6.63282,46.516,{"lat":1120,"lon":1119},[1123,1127],{"name":1124,"role":167,"phone":1125,"phoneExt":119,"email":1126},"Andreas Hottinger, MD","+41 79 556 97 74","Andreas.Hottinger@chuv.ch",{"name":1124,"role":163,"phone":119,"phoneExt":119,"email":119},{"facility":1129,"status":176,"city":1130,"state":119,"zip":119,"country":1115,"countryCode":1116,"cosmosGeoPoint":1131,"geoPoint":1135,"contacts":1136},"University Hospital Zurich","Zurich",{"type":183,"coordinates":1132},[1133,1134],8.55,47.36667,{"lat":1134,"lon":1133},[1137,1140],{"name":119,"role":167,"phone":1138,"phoneExt":119,"email":1139},"+41 44 255 55 11","neurologie@usz.ch",{"name":1141,"role":163,"phone":119,"phoneExt":119,"email":119},"Michael Weller, MD",{"type":1143,"investigatorFullName":119,"investigatorTitle":119,"investigatorAffiliation":119,"oldNameTitle":119,"oldOrganization":119},"SPONSOR",[1145,1148,1150,1152,1154,1156,1158,1160],{"name":1146,"class":1147},"Bayer","INDUSTRY",{"name":1149,"class":1147},"Kazia Therapeutics Limited",{"name":1151,"class":1147},"Kintara Therapeutics, Inc.",{"name":1153,"class":1147},"Biohaven Pharmaceuticals, Inc.",{"name":1155,"class":1147},"Vigeo Therapeutics, Inc.",{"name":1157,"class":1147},"Polaris Group",{"name":1159,"class":1147},"AstraZeneca",{"name":1161,"class":1162},"Knoa Pharma","UNKNOWN","100360233",false,"NCT03970447","A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma","GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II\u002FIII Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM","GBM AGILE","Newly Diagnosed Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.\n* Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from definitive surgery or biopsy.\n\nRecurrent Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).\n* Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.\n* Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.\n* Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from initial definitive surgery and\u002For, recurrent surgery, if performed.\n\nNewly Diagnosed Exclusion Criteria:\n\n* Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n\nRecurrent Exclusion Criteria:\n\n* Early disease progression prior to 3 months (12 weeks) from the completion of RT.\n* More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)\n* Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.\n* Any prior treatment with prolifeprospan 20 with carmustine wafer.\n* Any prior treatment with an intracerebral agent.\n* Receiving additional, concurrent, active therapy for GBM outside of the trial\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.","ALL","18 Years",{"count":1173,"type":1174},2250,"ESTIMATED","INTERVENTIONAL",[1177,1178],"PHASE2","PHASE3","Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II\u002FIII response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.\n\nAll institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\\*).",[1181],"Glioblastoma",[1181,1183,1184,1185,1186,1187,1188,1189,1190,1191,1192,1193],"Newly diagnosed","recurrent","O6-methylguanine-DNA-methyltransferase (MGMT) methylated","MGMT unmethylated","isocitrate dehydrogenase (IDH) wild-type","Bayesian","adaptive randomization","Master Protocol","Platform Trial","Phase 2","Phase 3","2026-06-24",{"date":1196,"type":1197},"2026-06-26","ACTUAL",{"date":1199,"type":1197},"2019-07-30",{"date":1201,"type":1174},"2030-06",{"name":5,"class":6},63]