drugset / Trial / NCT02560012

Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

NCT02560012

NaSingle-groupOpen-labelTreatment

Summary

This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and two for second-line therapy. Each of these drugs targets a specific molecular pathway. At present oncologists select therapy based on current guidelines. There is a new method for trying to use biomarker information from the subject's tumor to select the best drug to treat the subject. This process is investigational, which is why this study is being done. Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. These biomarkers build a tumor profile or "fingerprint" of the subject's tumor. A new focus in cancer care is personalized treatment, where doctors select a drug based on the subject's tumor's unique "fingerprint" which is more likely to be effective in fighting the tumor. Selecting the treatment the subject is more likely to respond to requires a thorough understanding of the relationship between biomarker and treatment effect. The PI wants to gather data to understand that relationship to help treat future cancer patients. The purpose of this study is to evaluate efficacy of treatments that are selected based on tumor profiles.

Timeline

Start
2016-01-04
Primary completion
2017-07-27
Completion
2017-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg Oral
Subject Everolimus Small molecule 10 mg Oral
Subject Pazopanib Small molecule 800 mg Oral
Subject Sorafenib Small molecule 400 mg Oral
Subject Sunitinib Small molecule 50 mg Oral
Subject Temsirolimus Small molecule 25 mg Intravenous

Indications