Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

Clinical Study With Axitinib (AG 013736) In Patients With Metastatic Renal Cell Carcinoma After Failure Of One Prior Systemic First-Line Therapy

This is a single arm study with axitinib in patients with advanced kidney cancer (clear cell variant), who have failed first line therapy. The study will recruit a maximum of 30 patients from 2 countries including Australia and Canada. Patients will be followed up for efficacy, safety and health related outcomes.

Inclusion Criteria:

• Metastatic renal cell carcinoma with a component of clear cell subtype.
• Prior first line systemic therapy
• At least 1 measurable lesion as per Response Evaluation Criterion in Solid Tumors [RECIST 1.1].
• Adequate hematology, liver and kidney functions
• Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1.
• Life expectancy of ≥12 weeks.
• Normotensive or well controlled hypertension (less than/equal to 140/90 mm Hg.)
• Negative pregnancy test
• Adequate recovery time from prior systemic therapy, surgery or radiation
• Willing and able subjects who have signed consent

Exclusion Criteria:

• More than one prior systemic therapy regimen
• Major bowel-penetrating surgery <4 weeks
• Active gastro intestinal bleed in past 3 months
• Active peptic ulcer disease in the past 6 months
• Current or anticipated use of potent CYP3A4/5 inhibitors
• Current or anticipated use of known CYP3A4/5 or CYP1A2 inducers
• Requirement for therapeutic warfarin or high dose steroids
• Symptomatic or untreated brain metastases
• A serious uncontrolled medical disorder or active infection
• Pregnant or breastfeeding females
• History of another active malignancy
• Dementia