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. 2020 Jun 29;22(11):1568–1579. doi: 10.1093/neuonc/noaa149

Table 3.

Summary of ongoing clinical trials that obtain tumor tissue for analysis as part of their protocols

Study Phase Number Number of Patients Recruitment Status Pathology Drug Dose Schedule Prior to Surgery Specimens Physiologic Effect
NCT01849146 Phase I 36 Recruiting Recurrent glioblastoma Adavosertib Not specified Not specified Tumor, blood pRb expression, Ki67, pCDC2, cleaved caspase 3
NCT01986348 Phase II 110 Active, not recruiting Recurrent gliomas Selinexor 60 mg twice per week 3 doses prior to surgery Tumor, blood
NCT02101905 Pilot 33 Active, not recruiting Recurrent high- grade glioma, EGFR amplified Lapatinib MTD Days −2, and 0, last dose 3 h prior to surgery Tumor Total and phospho- EGFR, Ki67
NCT02133183 Phase I 40 Active, not recruiting Recurrent glioblastoma Sapanisertib MTD Not specified Enhancing and non- enhancing tumor IHC for pS6, p4EBP, pmTOR, and AKTpSer473; pharmacokinetics in enhancing tumor
NCT02337686 Phase II 18 Active, not recruiting Recurrent glioblastoma Pembrolizumab 200 mg i.v. 2 doses q3weeks Tumor, blood Polyfunctional effector T cells:Treg ratio
NCT02525692 Phase II 76 Recruiting Recurrent glioblastoma ± H3 K27M mutation ONC201 Not specified Not specified Tumor Not specified
NCT02630030 Phase 0 3 Completed Recurrent or progressive glioblastoma Ixazomib Not specified Oral dose 3 h prior to surgery Tumor Pharmacokinetics in tumor tissue
NCT02850744 Phase II 10 Terminated Recurrent glioblastoma PQR309 80 mg For 3 consecutive days prior to surgery Tumor, CSF, skin Pharmacokinetics in cerebrospinal fluid
NCT02852655 Pilot 35 Active, not recruiting Glioblastoma Pembrolizumab Tumor, blood Tumor infiltrating T-lymphocyte density
NCT02933736 Early phase I 48 Unknown Meningioma Ribociclib 900 mg/d 5 doses then 3 cohorts: 2–4, 4–8, 22–26 h after admin Enhancing and non- enhancing tumor, CSF Glioblastoma cohort published35
NCT02981940 Phase II 36 Active, not recruiting Recurrent glioblastoma Abemaciclib b.i.d. Short preoperative course Enhancing tumor pRB expression level
NCT03122197 Phase 0/I 42 Recruiting Recurrent gliomas Letrozole 2–12 mg/d 1–5 days preop and continuing postop Enhancing tumor Area under the curve in tumor tissue
NCT03027388 Phase II 20 Recruiting Recurrent gliomas LBIOO 2.33 mg/m2 1–12 h prior to surgery Tumor tissues Pharmacokinetics parameters in tumor tissues
NCT03107780 Phase 0/I 86 Recruiting Recurrent glioblastoma AMG-232 Dose escalation 2 doses prior to surgery (q.d. dosing) Enhancing and nonenhancing tumor Pharmacokinetics parameters in tumor tissue