Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

Phase 2 Terminated 17 enrolled New Mexico Cancer Research Alliance

NaSingle-groupOpen-labelTreatment

Summary

This is an open label, non-randomized, single arm phase II study. The primary objective of this study is to investigate the efficacy of combination of sorafenib and VELCADE® (bortezomib). The primary efficacy endpoint is Progression-Free Survival (PFS). The secondary objectives of this study are to: Assess the response rate of this combination in this patient population and Assess the toxicity of this combination in this patient population

Timeline

Start: 2010-04
Primary completion: 2014-01
Completion: 2015-02

Outcome

Outcome not reported

Stopped (Enrollment): “Low accrual”

Publications

Rao A, Lauer R. Phase II study of sorafenib and bortezomib for first-line treatment of metastatic or unresectable renal cell carcinoma. Oncologist. 2015 Apr;20(4):370-1. doi: 10.1634/theoncologist.2015-0055. Epub 2015 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1 mg/m2	Intravenous
Subject	Sorafenib	Small molecule	200 mg	Oral