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Pazopanib in Treating Patients With Recurrent Glioblastoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459381
First received: April 9, 2007
Last updated: January 25, 2017
Last verified: January 2017
Results First Received: October 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions: Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects accrued between June 2007 to January 2008 at 4 NABTC Cancer Centers using their outpatient facilities. Survival follow-up extended to June 2009

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
Treatment (Pazopanib Hydrochloride)

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

pazopanib hydrochloride: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Pazopanib Hydrochloride)
STARTED   35 
COMPLETED   35 
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.
No text entered.

Reporting Groups
  Description
Treatment (Pazopanib Hydrochloride)

Patients receive oral pazopanib hydrochloride daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

pazopanib hydrochloride: Given orally

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Pazopanib Hydrochloride) 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Median (Full Range)
 53 
 (29 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  37.1% 
Male      22  62.9% 
Karnofsky Performance Status Scale [1] 
[Units: Participants]
 
90-100   26 
60-80   9 
[1] Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Prior Radiotherapy 
[Units: Participants]
 35 
Time from Radiotherapy to study enrollment 
[Units: Months]
Median (Full Range)
 10 
 (1 to 169) 
Number of Prior chemotherapy reginmens 
[Units: Participants]
 
 24 
 9 
 2 
Surgery for recurrence for current progression prior to enrollment 
[Units: Participants]
 
Yes   8 
No   27 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6 Months Progression-free Survival   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants Discontinuing Treatment Due to Toxicity   [ Time Frame: 2 years ]

3.  Secondary:   Most Common Toxicities Experienced After at Least One Dose of Pazopanib   [ Time Frame: Up to 2 years ]

4.  Secondary:   Overall Radiographic Response (ORR) Rate   [ Time Frame: 2 years ]

5.  Secondary:   Best Radiographic Response   [ Time Frame: 3 years ]

6.  Secondary:   Overall Survival   [ Time Frame: From date of registration to date of death due to any cause, assessed up to 2 years ]

7.  Secondary:   Time to Progression or Progression Free Survival   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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 text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mark Gilbert, MD
Organization: Adult Brain Tumor Consortium (ABTC)
phone: 410-955-8837
e-mail: jfisher@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00459381     History of Changes
Other Study ID Numbers: NCI-2012-02710
NABTC-0602
U01CA062399 ( U.S. NIH Grant/Contract )
CDR0000538083 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: April 9, 2007
Results First Received: October 12, 2016
Last Updated: January 25, 2017