Phase I study of direct administration of a replication deficient adenovirus vector containing vascular endothelial growth factor cDNA (CI-1023) to patients with claudication

2002 ◽  
Vol 11 (6) ◽  
pp. 85
Author(s):  
S. Rajagopalan ◽  
J. Trachtenberg ◽  
E. Mohler
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Phase I ◽  
Phase I Study ◽  
Adenovirus Vector ◽  
Vascular Endothelial ◽  
Direct Administration ◽  
Endothelial Growth Factor

scholarly journals Phase I Study of Intravenous Vascular Endothelial Growth Factor Trap, Aflibercept, in Patients With Advanced Solid Tumors

2010 ◽  
Vol 28 (2) ◽  
pp. 207-214 ◽  
Author(s):  
A. Craig Lockhart ◽  
Mace L. Rothenberg ◽  
Jakob Dupont ◽  
Wendy Cooper ◽  
Paul Chevalier ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Phase I ◽  
Solid Tumors ◽  
Phase I Study ◽  
Maximum Plasma ◽  
Vascular Endothelial ◽  
Dce Mri ◽  
Endothelial Growth Factor ◽  
Vegf Trap

Purpose Vascular endothelial growth factor (VEGF) Trap (aflibercept) is an angiogenesis inhibitor comprising portions of the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of human immunoglobulin G. This phase I study was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of VEGF Trap administered intravenously (IV) every 2 weeks. Patients and Methods Patients with refractory solid tumors or non-Hodgkin's lymphoma with adequate organ function were eligible. Pharmacokinetic/pharmacodynamic markers included measurement of plasma VEGF bound to VEGF Trap and free VEGF Trap. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) was incorporated to measure the biologic effects of the drug on tumor vascularity and permeability. Results The study enrolled 47 patients at doses ranging from 0.3 to 7.0 mg/kg IV every 2 weeks. Dose-limiting toxicities were rectal ulceration and proteinuria at the 7.0 mg/kg dose. Other mechanism-specific toxicities included hypertension. On the basis of these observations and on pharmacokinetics, the recommended phase II dose of VEGF Trap as a single agent is 4 mg/kg every 2 weeks. Three RECIST (Response Evaluation Criteria in Solid Tumors) –defined partial responses were observed, one at the 3.0 mg/kg and two at the 7.0 mg/kg dose level. Maximum plasma concentration of free VEGF Trap increased proportionally with dose. Maximal VEGF-bound VEGF Trap complex levels were reached at doses ≥ 2.0 mg/kg. Changes in volume transfer constant measured by DCE-MRI at baseline and at 24 hours after administration indicate a possible dose-related change in this pharmacodynamic marker. Conclusion IV VEGF Trap was well tolerated at the dose levels tested. Pharmacodynamic and pharmacokinetic markers were indicative of VEGF blockade.

scholarly journals A Phase I Study of Foretinib, a Multi-Targeted Inhibitor of c-Met and Vascular Endothelial Growth Factor Receptor 2

2010 ◽  
Vol 16 (13) ◽  
pp. 3507-3516 ◽  
Author(s):  
Joseph Paul Eder ◽  
Geoffrey I. Shapiro ◽  
Leonard J. Appleman ◽  
Andrew X. Zhu ◽  
Dale Miles ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Growth Factor ◽  
Phase I ◽  
Phase I Study ◽  
Growth Factor Receptor ◽  
Vascular Endothelial ◽  
Endothelial Growth Factor
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