Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma

Inclusion criteria

• . Age ≥ 18 years.
• . Metastatic or locally advanced (inoperable) pure type 1 or 2 or mixed PRCC, histologically confirmed by central review: relevant slides \[and blocks if available\] with the initial histology report must be sent for central reading before confirmation of inclusion.
• . No prior systemic treatment for metastatic renal cancer (chemotherapy, immunotherapy, anti-angiogenic drugs, or treatment under evaluation).
• . At least one measurable site of disease as defined by RECIST 1.1 criteria.
• . ECOG performance status of 0, 1.
• . No toxicity \> 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0)
• . In case of prior radiation therapy, discontinuation of irradiation for at least 4 weeks before first dose of study treatment. This period can be reduced to at least 1 week in case of radiotherapy in a limited field (\< 10% of the whole body) while no side effects grade ≥ 2 is expected and keeping at least one site for evaluation.
• . Adequate bone marrow, liver and renal function, as defined below:

Exclusion criteria