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A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma

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ClinicalTrials.gov Identifier: NCT00606008
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : October 31, 2012
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Anaplastic Astrocytoma
Glioblastoma
Intervention: Drug: Sunitinib Malate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients must have had pathologically or neuroradiographically recurrent AA or GB and prior pathologic confirmation of primary tumor histology. Patients with prior low-grade glioma were eligible if histological transformation to malignant astrocytic gliomas (MAG) was confirmed before enrollment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study patients were stratified by tumor histology (AAor GB).

Reporting Groups
  Description
Sutent Treatment

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.


Participant Flow:   Overall Study
    Sutent Treatment
STARTED   30 
COMPLETED   25 
NOT COMPLETED   5 
Adverse Event                1 
Withdrawal by Subject                4 



  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.
No text entered.

Reporting Groups
  Description
Sutent Treatment

Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.

Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study.


Baseline Measures
   Sutent Treatment 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   26 
>=65 years   4 
Age 
[Units: Years]
Median (Full Range)
 52 
 (30.0 to 77.0) 
Gender 
[Units: Participants]
 
Female   8 
Male   22 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures

1.  Primary:   Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse   [ Time Frame: 6 Months ]

2.  Secondary:   Best Overall Response   [ Time Frame: 12 Months ]

3.  Secondary:   Number of Participants With Related Grade 3 and Greater Adverse Events   [ Time Frame: 12 Months ]


  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
No definitive conclusions can be made regarding outcome differences between bevacizumab vs. bevacizumab-naive study patients, due to not enough patients who received bevacizumab prior to study enrollment (2 AA, 3 GB).


  More Information

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


Results Point of Contact:  
Name/Title: Dr. Edward Pan
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3871
e-mail: edward.pan@moffitt.org



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00606008     History of Changes
Other Study ID Numbers: MCC-14916
First Submitted: January 21, 2008
First Posted: February 1, 2008
Results First Submitted: October 2, 2012
Results First Posted: October 31, 2012
Last Update Posted: November 19, 2012