A Phase Ib Study of Cediranib in Combination With Cilengitide in Patients With Recurrent Glioblastoma
PRIMARY OBJECTIVES:
I. To determine the safety profile of cediranib (cediranib maleate) in combination with
cilengitide in patients with recurrent glioblastoma (Part A).
SECONDARY OBJECTIVES:
I. To estimate overall survival. II. To estimate the proportion of radiographic responses in
recurrent glioblastoma patients with measurable disease treated with cediranib and
cilengitide.
III. To estimate the proportion of patients alive and progression free at 6 months (APF6) in
patients with recurrent glioblastoma treated at the safe dose as determined in Part A (Part
B).
IV. To explore potential imaging techniques and biomarkers to capture the disease process
through treatment.
OUTLINE: This is a dose-escalation study of cediranib maleate. Patients are initially
enrolled in the dose-finding portion of the study (part A). Once the safe dose of cediranib
maleate is determined, additional patients are enrolled in the dose-expansion portion of the
study (part B).
Part A (dose finding): Patients receive cediranib maleate orally (PO) once daily on days
1-28 and cilengitide intravenously (IV) over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity.
Part B (dose expansion): Patients are assigned to 1 of 2 groups according to prior anti-VEGF
therapy (yes vs no). Patients in both groups receive cediranib maleate (administered at the
safe dose determined in part A) and cilengitide as in part A.
After completion of study therapy, patients are followed up every 2 months.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety profile of cediranib maleate based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
The proportion of patients with serious or life threatening toxicities will be estimated along with 95% confidence intervals.
28 days
Yes
Elizabeth Gerstner
Principal Investigator
National Cancer Institute (NCI)
United States: Food and Drug Administration
NCI-2012-02919
NCT00979862
March 2010
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Emory University | Atlanta, Georgia 30322 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Adult Brain Tumor Consortium | Baltimore, Maryland 21231-1000 |