A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas
- Determine the maximum tolerated dose of atrasentan in patients with progressive or
recurrent malignant glioma.
- Describe the pharmacokinetics of this drug in these patients.
- Assess preliminary evidence of therapeutic activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral atrasentan once daily. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1
patient experiences dose-limiting toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.
Primary Purpose: Treatment
Surasak Phuphanich, MD, FAAN
Winship Cancer Institute of Emory University
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|Abramson Cancer Center at University of Pennsylvania Medical Center||Philadelphia, Pennsylvania 19104|