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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

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