drugset / Trial / NCT01349088

Investigational Drug in Combination With Two Chemotherapy Drugs in Women With Locally Recurrent or Metastatic Breast Cancer

NCT01349088

NaSingle-groupOpen-labelTreatment

Summary

In 2008 there were more than 40,000 deaths caused by metastatic breast cancer in the United States. The development of new treatment strategies is essential to improve outcome for patients with metastatic breast cancer There is significant preclinical and clinical evidence indicating that creating new blood vessels (neoangiogenesis) to provide nutrients to solid tumors, including breast cancer, provides the necessary conditions to allow tumor growth. Vascular endothelial growth factor (VEGF) is one of the important molecules regulating new blood vessel formations and subsequent invasion and metastases. As a result, agents that inhibit VEGF are of substantial interest for the treatment of advanced diseases. This study will further the body of research of motesanib which has been shown in preclinical pharmacology and clinical pharmacology studies to be a potent, orally bioavailable multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, platelet-derived growth factor (PDGF), and Kit receptors.

Timeline

Start
2013-12
Primary completion
2015-09
Completion
2018-09

Drugs

EvaluationDrugModalityDoseRoute
Subject motesanib Small molecule 100 mg Oral
Subject motesanib Small molecule 125 mg Oral
Background Capecitabine Small molecule 2000 mg/m2
Background Ixabepilone Small molecule 40 mg/m2

Indications