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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Kidney Neoplasms

Treatments: Drug: Sorafenib; Drug: Axitinib (AG-013736)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920816

2010-018585-23 (EudraCT Number)

A4061051

Details and patient eligibility

About

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.

Enrollment: 492 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

492 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Axitinib (AG-013736)

B

Active Comparator group

Treatment:

Drug: Sorafenib