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Amgen 386 for Recurrent Glioblastoma

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
David Reardon, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01290263
First received: January 9, 2011
Last updated: June 4, 2017
Last verified: June 2017
Results First Received: January 17, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Drug: Amgen 386
Drug: Bevacizumab

  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
As of August 1, 2013, Cohort A was closed to new accrual following early interim analysis of first 10 participants enrolled on study showed insufficient efficacy per design.

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 A: AMG 386 30 mg/kg Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab

Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg.

Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
All Cohort B Participants: AMG 386 + Bevacizumab Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Cohort A: AMG 386 30 mg/kg   Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab   Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab   Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab   All Cohort B Participants: AMG 386 + Bevacizumab
STARTED   11   3   7   27   37 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   11   3   7   27   37 
Adverse Event                0                0                0                1                1 
Lack of Efficacy                8                2                7                24                33 
Withdrawal by Subject                3                1                0                1                2 
Participant Non-Compliance                0                0                0                1                1 



  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
Cohort B: AMG 386 + Bevacizumab All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
Cohort A: AMG 386 30 mg/kg All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Cohort B: AMG 386 + Bevacizumab   Cohort A: AMG 386 30 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   11   48 
Age 
[Units: Years]
Median (Full Range)
 63 
 (37 to 86) 
 62 
 (29 to 78) 
 62 
 (29 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  29.7%      5  45.5%      16  33.3% 
Male      26  70.3%      6  54.5%      32  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   9.1%      1   2.1% 
Not Hispanic or Latino      35  94.6%      10  90.9%      45  93.8% 
Unknown or Not Reported      2   5.4%      0   0.0%      2   4.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      35  94.6%      10  90.9%      45  93.8% 
More than one race      1   2.7%      1   9.1%      2   4.2% 
Unknown or Not Reported      1   2.7%      0   0.0%      1   2.1% 
Number of Prior Relapses 
[Units: Participants]
     
 23   8   31 
 14   2   16 
 0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]   [ Time Frame: 6 months ]

2.  Primary:   AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]   [ Time Frame: Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment. ]

3.  Primary:   AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]   [ Time Frame: Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment. ]

4.  Secondary:   Best Radiographic Response [Cohort A and Cohort B]   [ Time Frame: Disease was assessed radiographically for response every 8 weeks. ]

5.  Secondary:   Overall Survival (OS) [Cohort A and Cohort B]   [ Time Frame: Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days. ]

6.  Secondary:   Progression-Free Survival (PFS) [Cohort A and Cohort B]   [ Time Frame: Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days. ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David A. Reardon, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-2166
e-mail: dreardon3@partners.org



Responsible Party: David Reardon, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01290263     History of Changes
Other Study ID Numbers: 12-185
Study First Received: January 9, 2011
Results First Received: January 17, 2017
Last Updated: June 4, 2017