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

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: NCT01508117
Recruitment Status : Terminated (transferred study sponsor)
First Posted : January 11, 2012
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
Rekha Chaudhary, University of Cincinnati

Brief Summary:
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Axitinib Radiation: Radiation Therapy Phase 2

Detailed Description:
The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)
Study Start Date : August 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Drug: Axitinib
5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
Other Name: AG-013736
Radiation: Radiation Therapy
45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
Other Name: Hypofractionated radiation therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed patients with histologically proven glioblastoma multiforme
  • Age above 70 years
  • Karnofsky score of 50-80
  • Adequate organ function as defined by laboratory values
  • Life expectancy of >12 weeks
  • No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure readings must be 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.

Exclusion Criteria:

  • Prior treatment with chemotherapy or radiation for glioblastoma multiforme
  • Patients with extensive tumor hemorrhage
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01508117

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Rekha Chaudhury, MD University of Cincinnati

Responsible Party: Rekha Chaudhary, Adjunct Assistant Professor, University of Cincinnati Identifier: NCT01508117     History of Changes
Other Study ID Numbers: UCCR-2
First Posted: January 11, 2012    Key Record Dates
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017
Last Verified: December 2014

Keywords provided by Rekha Chaudhary, University of Cincinnati:
brain tumor

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action