Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

• Status: Completed
• Trial end date: 2016-02-25
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib; Sorafenib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis

• Evidence of measurable disease

• Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

• Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy

• Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug