Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

• Status: Completed
• Trial end date: 2021-04-29
• 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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Axitinib; Sorafenib

Criteria

Inclusion Criteria:

• Histologically documented metastatic renal cell cancer with a component of clear cell histology.

• Evidence of measurable disease.

• Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

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

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