PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients
treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic
development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and
venous thrombotic events (VTEs) were reported in patients treated in Part I.

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.