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AMG 102 and Avastin for Recurrent Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Katy Peters, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01113398
First received: April 28, 2010
Last updated: December 9, 2015
Last verified: December 2015
Results First Received: October 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma Multiforme
Gliosarcoma
Interventions: Drug: AMG 102
Drug: Avastin

  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
AMG 102 With Avastin

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.

AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.


Participant Flow:   Overall Study
    AMG 102 With Avastin  
STARTED     36  
COMPLETED     36 [1]
NOT COMPLETED     0  
[1] Completed= Discontinued study drug due to disease progression, death, toxicity or any other reason



  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.
No text entered.

Reporting Groups
  Description
AMG 102 With Avastin

Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.

AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.

Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.


Baseline Measures
    AMG 102 With Avastin  
Number of Participants  
[units: participants]
  36  
Age  
[units: years]
Mean (Standard Deviation)
  53.6  (11.1)  
Gender  
[units: participants]
 
Female     14  
Male     22  



  Outcome Measures
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1.  Primary:   Radiographic Response   [ Time Frame: 2 years ]

2.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 2 years ]

3.  Secondary:   Six-month Progression-free Survival (PFS6)   [ Time Frame: 6 months ]

4.  Secondary:   Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities   [ Time Frame: 2 years ]


  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
11/21/14 Amgen notified PI they stopped their own AMG102 studies due to increased risk found in the TX arm on a different study. Dr. Peters decided to stop TX on the 3 current subjects on her study at that time although no increased risks were found.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Katherine B. Peters, MD, PhD
Organization: Duke University Medical Center
phone: 919-684-6173
e-mail: katy.peters@duke.edu



Responsible Party: Katy Peters, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01113398     History of Changes
Other Study ID Numbers: Pro00022491
Study First Received: April 28, 2010
Results First Received: October 21, 2015
Last Updated: December 9, 2015
Health Authority: United States: Food and Drug Administration