A Phase I/II Trial of BAY 43-9006 plus Gemcitabine and Capecitabine in the Treatment of Patients with Advanced Renal Cell Carcinoma

Study Status

Closed to Enrollment

Study Description

This phase I/II trial is studying the side effects and best dose of sorafenib, gemcitabine, and capecitabine and to see how well they work in treating patients with unresectable and/or metastatic kidney cancer.

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with gemcitabine and capecitabine may kill more tumor cells.

Disease Status and/or Stage

Advanced, Unresectable and/or Metastatic Kidney Cancer


Weill Cornell Medical College, National Cancer Institute

Key Eligibility

  • Men and women age 18 and over
  • Diagnosed with unresectable and/or metastatic renal cell carcinoma (kidney cancer)
  • Must have received prior chemotherapy-based regimen
  • No prior chemotherapy or prior treatment with BAY 43-9006 and/or inhibitors of the MAPK or VEGF pathways
  • Additional eligibility criteria to be discussed when you contact the study team

Principal Investigator

Scott Tagawa, MD


Healthy Volunteers


As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.

Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

Top of page