NCT01253668

Brivanib Metastatic Renal Cell Carcinoma

Brivanib (BMS-582664, Brivanib Alaninate) in Treatment of Refractory Metastatic Renal Cell Carcinoma - A Phase II Pharmacodynamic and Baseline Biomarker Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study of an investigational agent, brivanib, in patients with refractory metastatic renal cell carcinoma. This study will evaluate the safety and effectiveness of brivanib in renal cell carcinoma, and explore the activity of this drug in this population to determine whether imaging and molecular features of the tumors can be used to predict response. Approximately 30 people with advanced kidney cancer will be enrolled on this study at the University of Pennsylvania.

Detailed description

The primary objective of 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 who 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 Von Hippel-Lindau gene (VHL) and hypoxia-inducible factor 1 gene (HIF-1) expression assessment and a novel histo-cytometric 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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Brivanib alaninate	Brivanib by mouth daily at a dose of 800mg.
GENETIC	Polymerase chain reaction	Undergo 1241-cG250 PET/CT imaging (correlative studies)
OTHER	Iodine I 124 chimeric monoclonal antibody G250	Undergo 124I-cG250 PET/CT imaging (correlative studies)
PROCEDURE	Positron emission tomography/computed tomography	Undergo 1241-cG250 PET/CT imaging (correlative studies)
GENETIC	Protein expression analysis	Correlative studies
OTHER	Immunohistochemistry	correlative studies

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-12-03
• Last updated: 2021-04-13
• Results posted: 2021-03-19

Locations

1 site across 1 country: United States