An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme
- To assess the progression-free survival rate at 6 months after treatment with
ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 in patients with recurrent
- To evaluate the acute and late toxicities associated with these regimens.
- To assess the objective tumor response rate.
- To estimate the overall survival of these patients.
- To describe the pharmacokinetic and pharmacodynamic profiles and immunogenicity of
OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 2 treatment
- Group 1: Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.
- Group 2: Patients receive anti-PDGFR alpha monoclonal antibody IMC-3G3 IV over 60-90
minutes on day 1. Courses repeat every 14 days in the absence of disease progression or
Patients undergo blood sample collection periodically for pharmacokinetic, pharmacodynamic
biomarker (i.e., PDGFRα, PDGF, VEGF, VEGFR-1, and VEGFR-2), and immunogenicity analyses.
After completion of study treatment, patients are followed every 2 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 6 months
Jaishri O. Blakeley, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|UAB Comprehensive Cancer Center||Birmingham, Alabama 35294|
|UCSF Medical Center at Parnassus||San Francisco, California 94143-0296|
|University of Pittsburgh School of Medicine||Pittsburgh, Pennsylvania 15232|