drugset / Trial / NCT01058655

RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer

NCT01058655

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators interfere with the VEGF pathway, the investigators inhibit this blood vessel growth which is required by tumors. One of the study drugs being used, tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another pathway involved in blood vessel and tumor cell growth. By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease.

Timeline

Start
2010-02
Primary completion
2013-09
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 5 mg Oral
Subject Everolimus Small molecule 10 mg Oral
Subject Tivozanib Small molecule 1 mg Oral
Subject Tivozanib Small molecule 1.5 mg Oral