- Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC.
The American Joint Committee on Cancer (AJCC) staging and classification criteria will
- ECOG performance status of 0-1.
- At least one measurable lesion per RECIST.
- Age greater than or equal to 20 years.
- Japanese, Chinese, or Korean ethnicity.
- CNS metastases at screening or history or CNS metastases.
- Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for
the treatment of RCC within 4 weeks before first dose of test article. Subjects must
have documented objective progressive disease after any prior systemic RCC treatment
and have recovered to grade 1 or lower toxicities from effects of prior systemic
therapy for RCC.
- In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell
carcinoma of the skin, or cervical carcinoma in situ).