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Table 1 Summary of clinical trials targeting survival and apoptosis pathways in GBM

From: Survival signalling and apoptosis resistance in glioblastomas: opportunities for targeted therapeutics

Target Drug (s) Trial design Study population Outcome Ref
EGFR Erlotinib Randomised, controlled, phase II #26032 110 Recurrent GBM 6-month PFS: 11.4% vs 24% control, Low akt borderline significance [34]
  Erlotinib (+RT+TMZ) Phase I/II cf historical controls #N0177 97 newly diagnosed GBM Median survival 15.3 months, no benefit at OS [41]
  Erlotinib (+RT +TMZ) Phase II cf historical controls 65 newly diagnosed GBM/gliosarcoma Median survival 19.3 months vs 14.1 controls, positive correlation MGMT methylation with survival and MGMT methylation + PTEN positivity with improved survival [40]
  Erlotinib (+RT +TMZ) Phase II 27 newly diagnosed GBM OS 8.6 months median PFS 2.8 months [42]
  Erlotinib (+RT+TMZ) Phase II #NCT00187486 Newly diagnosed GBM/gliosarcoma Ongoing http://www.clinicaltrials.gov  
  Erlotinib single-agent Phase II open-label, multicenter #NCT00337883 First Relapse GBM Completed http://www.clinicaltrials.gov  
  Gefitinib Phase II 53 Recurrent GBM 31 patients had radiographic progressive disease within the first 2 months, 51 progressed eventually median EFS: 8.1 weeks [53]
  Erlotinib +RT+TMZ) Phase II #NCT00274833 Newly diagnosed GBM Ongoing http://www.clinicaltrials.gov  
Akt Perifosine Phase II #NCT00590954 Recurrent/progressive Malignant Gliomas Ongoing http://www.clinicaltrials.gov  
  Perifosine and Temsirolimus Phase I/II #NCT01051557 Recurrent/progressive Malignant Glioma Planned, not yet recruiting http://www.clinicaltrials.gov  
  Nelfinavir (+TMZ +RT) Phase I/II #NCT00694837 Newly diagnosed GBM Recruiting http://www.clinicaltrials.gov  
PI3K/mTOR XL765 +TMZ Phase I #NCT00704080 Adults Malignant Gliomas   
mTOR Temsirolimus (CCI-779) Phase II 65 Recurrent GBM 6-month PFS: 7.8% median OS 4.4 months, high levels phospho p70s6K appear to predict benefit of treatment [60]
  Temsirolimus Phase II 43 Recurrent GBM No evidence of efficacy, 1 patient PF at 6-month: 2 PR, 20 SD, median time to progression 9 weeks [59]
  Temsirolimus (+TMZ+RT) Phase I #NCT00316849 newly diagnosed GBM Recruiting http://www.clinicaltrials.gov  
  Temsirolimus (+ Erlotinib+ Tipifarnib) Phase I/II #NCT00335764 recurrent GBM/gliosarcoma. Recruiting http://www.clinicaltrials.gov  
  Everolimus + gefitinib Phase I/II #NCT00085566 Progressive GBM Ongoing http://www.clinicaltrials.gov  
  Everolimus Phase I/II Pilot, Multicenter #NCT00515086 Recurrent GBM Completed, Decemeber 2009  
  Everolimus +AEE788 Phase IB/II multicenter, two-Arm, dose-escalation Recurrent GBM Ongoing http://www.clinicaltrials.gov  
Bcl-2 Gossypol Phase II #NCT00540722 Recurrent GBM Ongoing http://www.clinicaltrials.gov  
  Gossypol (AT-101) +RT +TMZ vs AT-101 +Adjuvant TMZ Phase I non-randomised #NCT00390403 Newly diagnosed GBM Completed, June 2009