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Trial record 37 of 230 for:    "Anaplastic oligodendroglioma"

Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors

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ClinicalTrials.gov Identifier: NCT00667394
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : August 31, 2012
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Mixed Oligoastrocytoma
Interventions: Biological: Bevacizumab
Drug: MLN-518 (Tandutinib)
Procedure: Quality-of-life assessment

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Tandutinib & Bevacizumab in GBM Patients GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
Tandutinib & Bevacizumab in AG Patients AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks

Participant Flow:   Overall Study
    Tandutinib & Bevacizumab in GBM Patients   Tandutinib & Bevacizumab in AG Patients
STARTED   41   1 
COMPLETED   37   1 
NOT COMPLETED   4   0 
Adverse Event                3                0 
Progressive disease                1                0 



  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
Tandutinib & Bevacizumab in GBM Patients GBM (glioblastoma multiforme) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.
Tandutinib & Bevacizumab in AG Patients AG (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, and malignant astrocytoma NOS (not otherwise specified )) Tandutinib 500 mg by mouth daily dose twice a day. Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks
Total Total of all reporting groups

Baseline Measures
   Tandutinib & Bevacizumab in GBM Patients   Tandutinib & Bevacizumab in AG Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   1   42 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   1   37 
>=65 years   5   0   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.16  (11.52)   63  (0)   54.37  (11.46) 
Gender 
[Units: Participants]
     
Female   12   0   12 
Male   29   1   30 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   38   1   39 
Unknown or Not Reported   3   0   3 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   0   3 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   3   0   3 
White   32   1   33 
More than one race   0   0   0 
Unknown or Not Reported   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   41   1   42 


  Outcome Measures

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

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 45 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 text entered.


  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: Dr. Katherine Warren
Organization: National Cancer Institute, National Institutes of Health
phone: 301-435-4683
e-mail: warrenk@box-w.nih.gov


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

Responsible Party: Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00667394     History of Changes
Other Study ID Numbers: 080101
08-C-0101
First Submitted: April 25, 2008
First Posted: April 28, 2008
Results First Submitted: July 30, 2012
Results First Posted: August 31, 2012
Last Update Posted: November 5, 2015