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