A Phase II Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Inhibitor In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

Inclusion Criteria:

- Adult male or female patients with histologically or cytologically confirmed renal
cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis

- Evidence of unidimensionally measurable disease

- Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment
of mRCC

- Part II: Evidence of disease progression following 1 prior regimen administered as
1st line therapy for mRCC. The prior regimen must have contained one of the
following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular
Endothelial Growth Factor] compounds, such as bevacizumab

- adequate bone marrow, liver and renal function

Exclusion Criteria:

Part I:

- Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain
the core platform antibody as PF 04856884

Part II:

- Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment
of mRCC and prior treatment with compounds which contain the core platform antibody
as PF 04856884

- major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy

- clinically significant gastrointestinal abnormalities

- current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and
drugs that are known CYP3A4 or CYP1A2 inducers

- history of bleeding diathesis or coagulopathy

- Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;

- hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.