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Panitumumab and Irinotecan for Malignant Gliomas

This study has been terminated.
(study did not reach benchmark efficacy rule at 16 subjects)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Annick Desjardins, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01017653
First received: November 19, 2009
Last updated: July 29, 2013
Last verified: July 2013
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Malignant Glioma of Brain
Interventions: Drug: Irinotecan
Drug: Panitumumab

  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
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Reporting Groups
  Description
Panitumumab and Irinotecan Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Panitumumab and Irinotecan  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Panitumumab and Irinotecan Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.

Baseline Measures
    Panitumumab and Irinotecan  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  48.73  ± 14.58  
Gender  
[units: participants]
 
Female     3  
Male     13  



  Outcome Measures
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1.  Primary:   6-month Progression-free Survival (PFS)   [ Time Frame: 6 months ]

2.  Secondary:   One-Year Overall Survival   [ Time Frame: 1 year ]

3.  Secondary:   Safety of Panitumumab in Combination With Irinotecan   [ Time Frame: 16 months ]

4.  Secondary:   Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose   [ Time Frame: Baseline and Day 29 ]

5.  Secondary:   Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity   [ Time Frame: 16 months ]

6.  Secondary:   Objective Response Rate   [ Time Frame: 16 months ]

7.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 18 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Annick Desjardins
Organization: Preston Robert Tisch Brain Tumor Center
e-mail: annick.desjardins@dm.duke.edu


No publications provided


Responsible Party: Annick Desjardins, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01017653     History of Changes
Other Study ID Numbers: Pro00015447
Study First Received: November 19, 2009
Results First Received: April 30, 2013
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration