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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Kidney Neoplasms

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00678392

AXIS TRIAL

A4061032

2008-001451-21 (EudraCT Number)

AXIS (Other Identifier)

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 after failure of one first line regimen.

Enrollment: 723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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723 participants in 2 patient groups

Axitinib

Experimental group

Treatment:

Drug: Axitinib (AG-013736)

Sorafenib

Active Comparator group

Treatment:

Drug: Sorafenib