NCT00678392

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00678392

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

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.

Eligibility

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

Disease(s) and\or Condition(s)

Kidney Neoplasms

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Axitinib (AG-013736)
- Description: axitinib will be given at a starting dose of 5 mg twice daily \[BID\] with continuous dosing
- Arm Group Labels: Axitinib
- Type: DRUG
- Name: Sorafenib
- Description: sorafenib will be given at a dose of 400 mg twice daily \[BID\] with continuous dosing
- Arm Group Labels: Sorafenib

Sponsor

Pfizer