Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

PHASE 2 STUDY OF AG-013736 AS SECOND-LINE TREATMENT IN PATIENTS WITH METASTATIC RENAL CELL CANCER

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Inclusion Criteria:

• Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
• Patients who are refractory to cytokine therapy as 1st line.
• Patients who experienced nephrectomy.
• Patients with at least 1 target lesion, as defined by RECIST.
• Patients with no uncontrolled hypertension.

Exclusion Criteria:

• Gastrointestinal abnormalities
• Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
• Active seizure disorder or evidence of brain metastases.
• Patients with hemoptysis.