Inclusion Criteria:

- ≥ 18 year old males or females

- Patients with recurrent or metastatic renal cell carcinoma (RCC) or primary RCC that
is not amendable to surgical intervention

- Histologically or cytologically confirmed renal cell carcinoma

- Measurable disease

- No more than one prior systemic treatment (chemotherapy or immunotherapy) for RCC.

- No active brain metastases

- Karnofsky performance status ≥ 70%, life expectancy ≥ 3 months

- No childbearing potential, or use of effective contraception during the study and for
4 weeks after the last dose of study drug

- Archival paraffin embedded tumor tissue, if available.

- Ability to give written informed consent

Exclusion Criteria:

- Pregnant or lactating women

- Primary CNS malignancies; active CNS metastases

- Hematologic malignancies (includes: leukemia, any form; lymphoma; and multiple
myeloma)

- Any of the following hematologic abnormalities:

- Hemoglobin ≤ 9.0 g/dL

- ANC < 1500 per mm3

- Platelet count < 100,000 per mm3

- Any of the following serum chemistry abnormalities:

- Total bilirubin > 1.5 × the ULN

- AST or ALT ≥ 2.5 × the ULN

- Serum albumin < 3.0 g/dL

- Creatinine > 1.7 × ULN (or calculated CLCR <50 mL/min/1.73 m2)

- Proteinuria > 2.5 g/24 hours or 4+ with urine dipstick

- Significant cardiovascular disease, including:

- Active clinically symptomatic left ventricular failure

- Active HTN (diastolic blood pressure > 100 mmHg). Patients with a history of
hypertension must have been on stable doses of anti-hypertensive drugs for ≥ 4
weeks

- Uncontrolled hypertension: Blood pressure >140/90 mmHg on more than 2
antihypertensive medications.

- Myocardial infarction within 3 months prior to administration of first study
dose

- Unhealed wounds (including active gastric ulcers)

- Serious/active infection; infection requiring parenteral antibiotics

- Inadequate recovery from prior antineoplastic therapy

- Inadequate recovery from any prior surgical procedure; major surgical procedure
within 4 weeks prior to study entry

- Life-threatening illness or organ system dysfunction compromising safety evaluation

- Psychiatric disorder, altered mental status precluding informed consent or necessary
testing

- Inability to comply with protocol requirements