NCT01508117

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

A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Axitinib	5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
RADIATION	Radiation Therapy	45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-01-11
• Last updated: 2017-09-19
• Results posted: 2017-09-19

Locations

1 site across 1 country: United States