RTOG-1122

Terminated

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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

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.