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

This study is currently recruiting participants.

Verified January 2012 by University of Cincinnati

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Olivier Rixe, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT01508117

First received: January 6, 2012

Last updated: January 10, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2012

Last Updated Date

January 10, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

overall survival [ Time Frame: average 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01508117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glioblastoma Multiforme

Intervention ^ICMJE

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

Study Arm (s)

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

Interventions:

Drug: Axitinib
Radiation: Radiation Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: UC Cancer Institute

513-584-7698

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01508117

Other Study ID Numbers ^ICMJE

UCCR-2

Has Data Monitoring Committee

Yes

Responsible Party

Olivier Rixe, University of Cincinnati

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Olivier Rixe, MD, PhD

University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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