drugset / Trial / NCT00536575

Sorafenib and Bortezomib Treatment for Relapsed or Refractory Multiple Myeloma Patients

NCT00536575

Phase 1/2 Completed 13 enrolled SCRI Development Innovations, LLC Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. The initial patients on the dose-finding portion of this study will be enrolled through a single institution. Following establishment of the Phase II dose the study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium. The purpose of this study is to develop the combination of bortezomib (which is proven to be clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of angiogenesis). This regimen will be developed in a schedule that is convenient for patients, and that is as minimally toxic to patients as possible.

Timeline

Start
2007-11
Primary completion
2010-02
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Intravenous
Subject Bortezomib Small molecule 1.6 mg/m2 Intravenous
Subject Sorafenib Small molecule 200 mg Oral
Subject Sorafenib Small molecule 400 mg Oral

Indications