RTOG-1122
Terminated
Protocol Information
Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab with or Without AMG 386 in Patients with Recurrent Glioblastoma or Gliosarcoma
Principal Investigator
Eudocia Quant Lee
Status
Terminated
Open to Accrual
March 13, 2013
Closed to Accrual
March 13, 2013
Closed to Accrual
September 2, 2014
Complete
June 9, 2021
Complete
May 5, 2021
Terminated
May 20, 2022
Disease Site
Brain [BN] Other
Phase
II
Developmental Therapeutics
No
Primary Objective
To assess the safety and tolerability of AMG 386 15 mg/kg weekly in combination with bevacizumab 10 mg/kg every 2 weeks (Cohort 1)
To assess the efficacy of AMG 386 in combination with bevacizumab 10 mg/kg every 2 weeks compared to bevacizumab monotherapy in bevacizumab-naïve patients, as measured by 6-month progression-free survival (PFS6) (Cohort 2)
Data Collection Notice:
Data for this trial is being collected via the NRG/RTOG Data Center.
Safety Reports
Safety reports for NRG-RTOG 1122 can be found here.
Patient Population
Recurrent glioblastoma or variant (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma)
Target Accrual
127