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

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. Identifier: NCT01663012
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : June 11, 2015
Last Update Posted : February 24, 2016
Nektar Therapeutics
Information provided by (Responsible Party):
Lawrence Recht, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Anaplastic Astrocytomas
Anaplastic Oligodendrogliomas
Glioblastomas (GBM)
Intervention: Drug: Etirinotecan pegol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Drug: Etirinotecan Pegol

145 mg/m2 dose

Etirinotecan pegol

Participant Flow:   Overall Study
    Drug: Etirinotecan Pegol

  Baseline Characteristics

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
Drug: Etirinotecan Pegol

145 mg/m2 dose

Etirinotecan pegol

Baseline Measures
   Drug: Etirinotecan Pegol 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   17 
>=65 years   3 
[Units: Years]
Median (Full Range)
 (20 to 73) 
[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

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

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

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

Responsible Party: Lawrence Recht, Stanford University 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 )
First Submitted: August 2, 2012
First Posted: August 13, 2012
Results First Submitted: May 28, 2015
Results First Posted: June 11, 2015
Last Update Posted: February 24, 2016