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

January 6, 2012
January 10, 2012
January 2012
December 2015   (final data collection date for primary outcome measure)
overall survival [ Time Frame: average 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01508117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
  • 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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
68
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact: UC Cancer Institute 513-584-7698
United States
 
NCT01508117
UCCR-2
Yes
Olivier Rixe, University of Cincinnati
University of Cincinnati
Pfizer
Principal Investigator: Olivier Rixe, MD, PhD University of Cincinnati
University of Cincinnati
January 2012

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