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Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

This study has been terminated.
(transferred study sponsor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508117
First Posted: January 11, 2012
Last Update Posted: September 19, 2017
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.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rekha Chaudhary, University of Cincinnati
Results First Submitted: August 18, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glioblastoma Multiforme
Interventions: Drug: Axitinib
Radiation: Radiation Therapy

  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
Recruitment period 8/10/11-10/26/12

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
Axitinib + Radiation Therapy

Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity

Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy


Participant Flow:   Overall Study
    Axitinib + Radiation Therapy
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide 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
Axitinib + Radiation Therapy

Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity

Axitinib: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Radiation Therapy: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy


Baseline Measures
   Axitinib + Radiation Therapy 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      1 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1 100.0% 
White      0   0.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: average 1 year ]


  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
Early termination due to lack of accrual.


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


Results Point of Contact:  
Name/Title: Alison Kastl
Organization: University of Cincinnati
phone: 513-584-0436
e-mail: kastla@ucmail.uc.edu



Responsible Party: Rekha Chaudhary, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01508117     History of Changes
Other Study ID Numbers: UCCR-2
First Submitted: January 6, 2012
First Posted: January 11, 2012
Results First Submitted: August 18, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017