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

Stopped early · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT01508117

Run by

University of Cincinnati

People needed

1

Starts

2011-08-01

Expected to finish

2012-10-01

Last updated by the study team

2017-09-19

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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