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Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma

This study has been completed.
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
Lawrence Recht, Stanford University
ClinicalTrials.gov Identifier:
NCT01663012
First received: August 2, 2012
Last updated: January 25, 2016
Last verified: January 2016
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Astrocytomas
Anaplastic Oligodendrogliomas
Glioblastomas (GBM)
Intervention: Drug: Etirinotecan pegol

  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
Drug: Etirinotecan Pegol

145 mg/m2 dose

Etirinotecan pegol


Participant Flow:   Overall Study
    Drug: Etirinotecan Pegol  
STARTED     20  
COMPLETED     20  
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
Drug: Etirinotecan Pegol

145 mg/m2 dose

Etirinotecan pegol


Baseline Measures
    Drug: Etirinotecan Pegol  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     3  
Age  
[units: years]
Median (Full Range)
  49.5  
  (20 to 73)  
Gender  
[units: participants]
 
Female     8  
Male     12  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     19  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     16  
More than one race     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria   [ Time Frame: 6 weeks from first administration of NKTR-102 ]

2.  Secondary:   Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death   [ Time Frame: From date of first dose of NKTR-102 to date of death, assessed up to 2 years ]

3.  Secondary:   Overall Survival From Time of Diagnosis   [ Time Frame: From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 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
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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: Lawrence Recht, MD, Professor of Neurology
Organization: Stanford University School of Medicine650-
phone: 650-725-8630
e-mail: lrecht@stanford.edu



Responsible Party: Lawrence Recht, Stanford University
ClinicalTrials.gov Identifier: NCT01663012     History of Changes
Other Study ID Numbers: IRB-24833
SU-06212012-10228 ( Other Identifier: Stanford University )
NCI-2012-01288 ( Other Identifier: National Cancer Institute )
BRN0021 ( Other Identifier: OnCore )
Study First Received: August 2, 2012
Results First Received: May 28, 2015
Last Updated: January 25, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board