A Phase I/II Study of GTI-2040 and Capecitabine Combination Therapy in Patients With Advanced or Metastatic Renal Cell Carcinoma (mRCC)

Inclusion Criteria

- Age greater than or equal to 18.

- Histologically or cytologically confirmed diagnosis of advanced or metastatic renal
cell carcinoma for which no effective therapy is available or that is unresponsive to
conventional therapy.

- Measurable disease. To be considered measurable, a lesion must be accurately
measured in at least one dimension (longest diameter to be recorded) as greater than
or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm
with spiral CT scan.

- Karnofsky performance status of greater than or equal to 70.

- Be able to have a central venous like access maintained throughout the study.

- Provide written informed consent prior to the initiation of protocol therapy.

- Appropriate organ function.