drugset / Trial / NCT01453595

BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)

NCT01453595

NaSingle-groupOpen-labelTreatment

Summary

This study tests a new medication for treatment of kidney cancer, called BEZ235. This medication works by blocking several mechanisms that the cancer needs to grow and survive. By blocking these mechanisms, the medication can thus suppress further growth of the cancer, possibly kill cancer cells. Older kidney cancer medications (such as temsirolimus \[Torisel®\] or everolimus \[Afinitor®\]) typically only block one mechanism in cancer cells, so the investigators think that BEZ235 may work even better against kidney cancer. The purpose of the first part of this study is to test the safety of giving BEZ235 at different doses. The investigators are trying to find a safe dose of BEZ235 and want to find out what effects, good and/or bad, it has on the patient and the cancer.

Timeline

Start
2011-10
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dactolisib Small molecule 300 mg Oral
Subject Dactolisib Small molecule 400 mg Oral
Subject Dactolisib Small molecule 600 mg Oral
Subject Dactolisib Small molecule 800 mg Oral

Indications