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Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609790
First Posted: June 1, 2012
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: October 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Giant Cell Glioblastoma
Glioblastoma
Gliosarcoma
Oligodendroglioma
Recurrent Brain Neoplasm
Recurrent Glioblastoma
Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
Biological: Trebananib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1: Safety Run-In Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
Cohort 2: Bevacizumab+Placebo Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
Cohort 2: Bevacizumab+AMG 386 Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.

Participant Flow:   Overall Study
    Cohort 1: Safety Run-In   Cohort 2: Bevacizumab+Placebo   Cohort 2: Bevacizumab+AMG 386
STARTED   7   65   65 
COMPLETED   6 [1]   58 [1]   57 [1] 
NOT COMPLETED   1   7   8 
Protocol Violation                1                7                8 
[1] Subjects with data available for analysis are considered to have completed the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients.

Reporting Groups
  Description
Cohort 1: Safety Run-In Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
Cohort 2: Bevacizumab+Placebo Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
Cohort 2: Bevacizumab+AMG 386 Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Safety Run-In   Cohort 2: Bevacizumab+Placebo   Cohort 2: Bevacizumab+AMG 386   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   58   57   121 
Age 
[Units: Years]
Median (Full Range)
 56 
 (28 to 75) 
 58 
 (22 to 79) 
 57 
 (30 to 80) 
 58 
 (22 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  16.7%      22  37.9%      25  43.9%      48  39.7% 
Male      5  83.3%      36  62.1%      32  56.1%      73  60.3% 


  Outcome Measures
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1.  Primary:   Incidence of Dose-limiting Toxicity (Cohort 1)   [ Time Frame: From start of treatment to 4 weeks. ]

2.  Primary:   Six-month Progression-free Survival (Cohort 2)   [ Time Frame: From randomization to six months. ]

3.  Secondary:   Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)   [ Time Frame: From start of treatment up to 3 years. ]

4.  Secondary:   Overall Survival (Cohort 2)   [ Time Frame: From randomization up to 3 years. ]

5.  Secondary:   Progression-free Survival (Cohort 2)   [ Time Frame: From randomization up to 3 years. ]

6.  Secondary:   Radiographic Response Rate (Cohort 2)   [ Time Frame: From randomization up to 3 years. ]

7.  Secondary:   Feasibility of Trebananib Weekly in Combination With Bevacizumab Every 2 Weeks, Measured by the Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)   [ Time Frame: From randomization up to 3 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)   [ Time Frame: From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01609790     History of Changes
Other Study ID Numbers: NCI-2012-01969
NCI-2012-01969 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000734205
RTOG-1122
RTOG-1122 ( Other Identifier: NRG Oncology )
RTOG-1122 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: May 30, 2012
First Posted: June 1, 2012
Results First Submitted: October 25, 2016
Results First Posted: February 27, 2017
Last Update Posted: August 25, 2017



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