drugset / Trial / NCT00618982

Sorafenib Dose Escalation in Renal Cell Carcinoma

NCT00618982 ↗

Phase 2 Completed 83 enrolled Bayer
NaSingle-groupOpen-labelTreatment

Summary

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors. This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

Timeline

Start
2008-02
Primary completion
2009-04
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 800 mg Oral

Indications