A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma
Primary interest for combining SU011248 w irinotecan in malignant glioma pts derives from
dramatic anti-tumor activity recently demonstrated among RMG pts treated w humanized
anti-VEGF monoclonal antibody, bevacizumab, when combined w irinotecan. 63 percent
radiographic response rate was observed following treatment w regimen every other wk, &
median progression-free survival was 23wks. Similar enhancement of chemo activity by
VEGF-directed therapy w bev has been previously demonstrated for colorectal & lung cancer
pts. SU011248 is being evaluated in current regimen because it may exert more potent
anti-angiogenic effect than bev among MG pts due to its ability to inhibit PDGFR-mediated
pericyte stabilization in tumor neovasculature.
Current proposed ph I study is designed to determine MTD & DLT of SU011248 when combo w
irinotecan for pts w RMG. Both SU01148 & irinotecan are known to be metabolized by CYP3A4
cytochrome system. Current study will limit enrollment to pts who are not on CYP3A4-enzyme
inducing anti-epileptic drugs.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine MTD & DLT of SU011248 + Irinotecan in pts w RMG not on EIAEDs
6 months
No
David A. Reardon, MD
Principal Investigator
Duke University Health System
United States: Institutional Review Board
Pro00000931
NCT00611728
March 2008
September 2010
Name | Location |
---|---|
Duke University Health System | Durham, North Carolina 27705 |