- Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy
status) with well-documented Radiological PD by RECIST criteria or clinical PD as
judged by the investigator while receiving first-line sunitinib therapy. Subjects must
have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
- At time of randomization, at least 2 weeks since prior treatment with sunitinib,
palliative radiation therapy, and/or surgery.
- At time of randomization, there must be at least 1 measurable lesion per RECIST.
Lesions that have been previously irradiated or embolized cannot be selected as target
lesions.
- More criteria apply
- Metastatic CNS from RCC.
- Subjects who discontinued Sutent therapy due specifically to intolerance.
- Prior systemic therapy for mRCC other than sunitinib.
- Active ketonuria, secondary to poorly controlled diabetes mellitus
- More criteria apply