Brivanib (BMS-582664, Brivanib Alaninate) in Treatment of Refractory Metastatic Renal Cell Carcinoma - A Phase II Pharmacodynamic and Baseline Biomarker Study
The primary objectiveof this clinical trial is to determine the efficacy of brivanib in the
treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) in
patients whi have progressed on treatment with sunitinib, sorafenib, bevacizumab, or
pazopanib. The primary endpoint of the trial will be PFS at 16 weeks. The secondary
objectives are to further examine the safety and tolerability profile of brivanib, to
examine the efficacy of brivanib in this population in terms of best overall response,
response rate, progression-free survival, and overall survival, to describe baseline and
changes in I-cG250 PET/CT in relation to observed therapeutic effects., to describe novel
baseline histologic features of these tumors in relation to observed therapeutic effects.
Modalities will include VHL and HIF expression assessment and a novel 'histocytometric'
assessment of the tumor microenvironment in terms of p-STAT3, p-ERK, Ki67, VEGFR2, FGFR1
expression., to describe changes in circulating collagen IV on brivanib in relation to
therapeutic effects., to explore the relationship between single nucleotide polymorphisms in
angiogenesis-related genes and the activity of brivanib in the treatment of these patients.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
All patients will be followed through the entire 16-week period and will be given a binary outcome assignment: progressive disease or not.
Stephen Keefe, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|