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Clinical Trial Details

Trial Information
 
Trial:  Kidney Cancer - A Phase II Study of M200
   
 
Co-Investigator(s):  Arie Belldegrun, MD;
   
This trial is currently accepting new patient applications.  (Apply)


Objective
 

A Phase II Study of M200 (anti-a 5ß1 integrin monoclonal antibody) in Patients with Metastatic Renal Cell Carcinoma

 

M200 is an anti-angiogenic a5ß1 integrin inhibitor for the treatment of solid tumors.  M200 binds to a5ß1 integrin and blocks the binding of a5ß1 to fibronectin, thereby inhibiting a pivotal interaction required for angiogenesis.  This mechanism of action is different from other angiogenesis inhibitors currently approved or in clinical trials, which primarily focus on inhibiting vascular endothelial growth factor (VEGF).

Principal investigator: Fairooz Kabbinavar - Hematology-Oncolory



Patient Eligibility
 

Inclusion Criteria:

  • Metastatic RCC with predominantly clear cell histology
  • Previously treated with 0 to 2 prior regimens for metastatic disease
  • Measurable Disease per RECIST criteria
  • Performance Status 0-1

 

Exclusion Criteria
  • Any of the following histologies:  papillary, chromophobe, collecting duct, or unclassified.
  • CNS Tumor or metastasis
  • Within the past year: stroke, TIA, DVT , bleeding disorder, GI ulcer, a history of GI bleed requiring transfusion, hemoptysis, coagulation defects. 
  • Diabetes requiring insulin, uncontrolled hypertension
  • Unstable cardiac disease
  • Coumadin (high-dose) therapy


For More Information
  For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.